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TECO DIAGNOSTICS

Last updated September 17, 2026

Information

Country: US
Address: 1268 NORTH LAKEVIEW AVE., ANAHEIM, CA, 92807
Website: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1832216
DUNS Number: —

Catalogue (245)

Page 5 of 5

Device	Model / Reference	Registries	Class	Status
Amylase Reagent Set (kinetic)	K931080	FDA 510(k)	Class II	Active
Teco Diagnostics Uti Detection Strips	K100024	FDA 510(k)	Class I	Active
Teco Diagnostics Saliva Alcohol Test	K111206	FDA 510(k)	Class II	Active
One -step Urine/Serum Combo Pregnancy Card Test	K964461	FDA 510(k)	Class II	Active
Clinistrip	K970250	FDA 510(k)	Class II	Active
Amylase Liquid Reagent, Model A532-200	K040920	FDA 510(k)	Class II	Active
Teco Ise Reagent Set For Cx System	K052724	FDA 510(k)	Class II	Active
Cocaine Dipstick Test, Model D747-A	K010239	FDA 510(k)	Class II	Active
Urea Nitrogen (bun) Liquid Reagent	K981106	FDA 510(k)	Class II	Active
Multi Analyte Linearity Set	K936245	FDA 510(k)	Class I	Active
Bile Acids Reagent Set	K970120	FDA 510(k)	Class II	Active
Carbon Dioxide (c02)	K942735	FDA 510(k)	Class II	Active
Lipase Reagent Set (colipase Method)	K970124	FDA 510(k)	Class I	Active
Direct Ldl Cholesterol, Model L530-60h	K051121	FDA 510(k)	Class I	Active
Teco Homocysteine Enzymatic Assay	K063701	FDA 510(k)	Class II	Active
Uritek-720+ Urine Analyzer	K051526	FDA 510(k)	Class I	Active
One Step Marijuana Card Test	K970548	FDA 510(k)	Class II	Active
Urs-2gp (glucose Protein) Urine Strips	K131600	FDA 510(k)	Class II	Active
Urine Reagents Strips-8 Parameters (modification)	K954977	FDA 510(k)	Class I	Active
Creatine Kinase Liquid Reagent, Model C519-440	K072548	FDA 510(k)	Class II	Active
Uritek Tc-201 Urine Chemistry Test System	K152835	FDA 510(k)	Class II	Active
Teco Creatinine Enzymatic Reagent Kit	K161527	FDA 510(k)	Class II	Active
One-Step Dipstick Pregnancy Test	K964536	FDA 510(k)	Class II	Active
Scanostics UTI Check Application Test System	K170118	FDA 510(k)	Class I	Active
Urs-1b (blood Test)	K023297	FDA 510(k)	Class II	Active
Fecal Occult Blood Card Test, Model F735-A, Fecal Occult Blood Card Kit, Model F735-25	K061065	FDA 510(k)	Class II	Active
Teco Microalbumin 2-1 Combo Strips	K061419	FDA 510(k)	Class I	Active
Uritek Tc-101 Urine Analyzer, Urine Reagent Strips 10, Models Tc-101, Urs-10	K101673	FDA 510(k)	Class II	Active
Hemoglobin A1c Reagent Set	K051200	FDA 510(k)	Class II	Active
Urine Reagent Strips-8 Parameters	K943436	FDA 510(k)	Class I	Active
Serum @-Hydroxybutyrate Dehydrogenase (hbdh)	K941427	FDA 510(k)	Class I	Active
Urs-Ig (glucose Test)	K020175	FDA 510(k)	Class II	Active
Vacu Lab Plain Tube, Vacu Lab Gel & Clot Activator Tube, Vacu Lab Coagulation Tube	K060364	FDA 510(k)	Class II	Active
One-Step Urine/Serum Comno Pregnancy Dipstick Test	K964462	FDA 510(k)	Class II	Active
Urine Reagent Strip-3 Parameters	K940469	FDA 510(k)	Class II	Active
Thyroid Stiumlating Hormone (tsh-Beads Assay) Test	K961629	FDA 510(k)	Class II	Active
C-Reactive Protein (crp):a Latex Slide Test	K962019	FDA 510(k)	Class II	Active
Alkaline Phosphatase Liquid Reagent-Kinetic, Models A504-150 And A504-500h	K000067	FDA 510(k)	Class II	Active
Glycohemoglobin	K931183	FDA 510(k)	Class II	Active
Glucose (hexokinase) Liquid Reagent, Model G518-150	K000102	FDA 510(k)	Class II	Active
Urine Reagent Strips-3 Parameters (modification)	K955438	FDA 510(k)	Class I	Active
Direct Hdl Cholesterol And Direct Hdl/Ldl Calibrator	K050823	FDA 510(k)	Class I	Active
Ast/Sgot Liquid Reagent - Kinetic Method	K981650	FDA 510(k)	Class II	Active
In Vitro Diagnostic Urine Reagent Strips Set	K942648	FDA 510(k)	Class II	Active
Urs-1k (ketone Tesst)	K003987	FDA 510(k)	Class I	Active

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FDA Recalls (10)

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
Oct 14, 2011	Z-0512-2012	—	terminated	This recall was initiated in response to findings during a FDA inspection of the firm. The firm's recall has been initiated due to improper manufacture of sub-component nitrite paper Lot 35134, Expiration Date: 01/2014. Discrepancies were found on the information recorded on formulation sheet and manufacturing log sheets. Sampling size submitted for QC testing was insufficient based upon number o
Oct 14, 2011	Z-0511-2012	—	terminated	This recall was initiated in response to findings during a FDA inspection of the firm. The firm's recall has been initiated due to improper manufacture of sub-component nitrite paper Lot 35134, Expiration Date: 01/2014. Discrepancies were found on the information recorded on formulation sheet and manufacturing log sheets (Refer to next paragraph). Sampling size submitted for QC testing was insuff
Oct 1, 2010	Z-0578-2011	—	terminated	This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di
Oct 1, 2010	Z-0579-2011	—	terminated	This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di
Oct 1, 2010	Z-0577-2011	—	terminated	This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di
Oct 1, 2010	Z-0582-2011	—	terminated	This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di
Oct 1, 2010	Z-0581-2011	—	terminated	This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di
Oct 1, 2010	Z-0580-2011	—	terminated	This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di
Oct 1, 2010	Z-0583-2011	—	terminated	This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di
Dec 22, 2005	Z-0472-06	—	terminated	When reading the Nitrite parameter on the Teco Diagnostics URS-10 strips, some positive nitrite samples may be read by the machine as negative.