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Polymer Technology Systems

Last updated September 17, 2026

Information

Country: US
Address: 4600 Anson Boulevard, Whitestown, IN, 46075
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LinkedIn: —
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Phone: —
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EUDAMED SRN: —
FDA FEI Number: 3002698769
DUNS Number: —

Catalogue (89)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus Home	REF 4747	FDA UDI	Class I	Active
CardioChek Plus Home Self-Test Analyzer	4750	FDA UDI	Class I	Active
CardioChek Plus Home Self-Test Analyzer	4720	FDA UDI	Class II	Active
PTS Panels® Ketones Test Strips	1718	FDA UDI	Class I	Unknown
PTS Panels® Glucose Test Strips (25-ct)	1713	FDA UDI	Class II	Active
PTS Connect™ Universal Solution	3771	FDA UDI	Class I	Active
A1CNow+ Controls™ Levels 1+2	737	FDA UDI	Class I	Active
CardioChek® PA Professional Analyzer, Refurbished	1757	FDA UDI	Class I	Active
pts panels® HDL Cholesterol Controls	722	FDA UDI	Class I	Active
pts collect™ Capillary Tubes	2863	FDA UDI	Class I	Active
CardioChek® Analyzer	1709	FDA UDI	Class I	Active
CardioChek® PA analyzer	1708	FDA UDI	Class I	Active
Bioscanner Triglycerides Test Strips	K991894	FDA 510(k)	Class I	Active
Bioscanner Beyond Glucose Analyzer And Test Strips	K013203	FDA 510(k)	Class II	Active
Pts Panels Ldl Cholesterol Test Strips	K040693	FDA 510(k)	Class I	Active
Pts Panels Chol+glu Test Panel	K041750	FDA 510(k)	Class II	Active
BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System	K142302	FDA 510(k)	Class II	Active
Bioscanner 2000	K013068	FDA 510(k)	Class II	Active
Mtm Bioscanner K Test Strips, Cat # Bsa610	K983860	FDA 510(k)	Class I	Active
Pts Panels Multi-Chemistry Controls	K022401	FDA 510(k)	Class I	Active
Pts Panels Metabolic Chemistry Panel Test Strips	K070017	FDA 510(k)	Class II	Active
Cardiochek Plus Test System, Cardiochek Home Test System	K140068	FDA 510(k)	Class II	Active
Mtm Bioscanner C Test Strips	K990688	FDA 510(k)	Class I	Active
Bioscanner Plus; Lipid Panel Test Strips	K013173	FDA 510(k)	Class I	Active
Pts Panels Lipid Panel Test Strips	K022898	FDA 510(k)	Class I	Active
Mtm Bioscanner Hdl Test Strips, Over The Counter (otc)	K993377	FDA 510(k)	Class I	Active
Mtm Bioscanner K Test Strips	K981865	FDA 510(k)	Class I	Active
Bioscanner Creatinine Test Strips	K010456	FDA 510(k)	Class II	Active
Mtm Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220	K981493	FDA 510(k)	Class I	Active
Pts Panels Lipid Panel Test Strips	K023558	FDA 510(k)	Class I	Active
Pts Panels Chol+hdl+glu Panel Test Strips	K071507	FDA 510(k)	Class II	Active
CardioChek Plus Test System	K151530	FDA 510(k)	Class II	Active
Bioscanner Plus	K014099	FDA 510(k)	Class II	Active
Mtm Bioscanner Hdl, Model # Bsa450, Bsa460, Bsa470	K990247	FDA 510(k)	Class I	Active
Mtm Bioscanner 1000 Test System Consisting Of Mtm Bioscanner 1000 Meter, Mtm Bioscanner G Test Strip, Norman Glucose Con	K972669	FDA 510(k)	Class II	Active
Bioscanner Triglycerides Test Strips	K000586	FDA 510(k)	Class I	Active
Pts Panels Hdl Cholesterol Test Strips	K060617	FDA 510(k)	Class I	Active
Pts Panels Chol+hdl Panel Test Strips	K071593	FDA 510(k)	Class I	Active
CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System	K151545	FDA 510(k)	Class I	Active

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FDA Recalls (25)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 21, 2020	Z-1438-2020	—	terminated	The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
Dec 2, 2019	Z-0834-2020	—	terminated	One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
Dec 2, 2019	Z-0833-2020	—	terminated	One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
Dec 2, 2019	Z-0835-2020	—	terminated	One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
Dec 2, 2019	Z-0832-2020	—	terminated	One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
Jun 7, 2019	Z-2157-2019	—	terminated	The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
Jun 7, 2019	Z-2158-2019	—	terminated	The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
Jan 16, 2019	Z-1372-2019	—	terminated	Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
Jan 16, 2019	Z-1371-2019	—	terminated	Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed.
Jan 16, 2019	Z-1373-2019	—	terminated	Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed
Mar 14, 2018	Z-1543-2018	—	terminated	Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)
Dec 2, 2016	Z-0683-2020	—	terminated	A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Dec 2, 2016	Z-0685-2020	—	terminated	A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Dec 2, 2016	Z-0682-2020	—	terminated	A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Dec 2, 2016	Z-0684-2020	—	terminated	A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Dec 2, 2016	Z-0686-2020	—	terminated	A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Mar 15, 2016	Z-0741-2020	—	terminated	This lot of test strips is showing an under-recovery when tested against a reference method.
Apr 4, 2013	Z-1403-2013	—	terminated	Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.
May 15, 2012	Z-1903-2012	—	terminated	During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the CardioChek PA meter for the creatinine assay.
Jul 6, 2010	Z-2641-2010	—	terminated	The test strips appear to under-recover Cholesterol, HDL and glucose.
Aug 4, 2009	Z-1012-2010	—	terminated	Possible under recovery of cholesterol, HDL and glucose. A loss of recoverable cholesterol and HDL cholesterol is a manageable to moderate health risk. The clinical applications analysis shows that lot 1891 shows such a loss of activity. A loss of recoverable Glucose measurement is a moderate to high risk, based upon the degree of under-recovery, and the frequency of occurrence.
Jun 5, 2009	Z-1136-2010	—	terminated	Exhibits under-recovery of all analytes.
Apr 2, 2009	Z-0871-2010	—	terminated	The memory chip was coded with incorrect product information.
Feb 20, 2009	Z-0975-2010	—	terminated	Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009 expiration date.
May 29, 2008	Z-1132-2010	—	terminated	The expiration date was extended by 20 weeks without justification.