Em Diagnostic Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 288
What Em Diagnostic Systems, Inc. makes
Em Diagnostic Systems, Inc. manufactures diagnostic test kits and reagents for clinical chemistry, including assays for alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, amylase, glucose, uric acid, and phenobarbital. Their portfolio also includes calibrators and control materials, such as the Auto Trol™ Control and EMDS calibrators, designed for laboratory use in measuring blood chemistry parameters.
The company’s products are regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. These products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. Em Diagnostic Systems, Inc. is based in the United States.
AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.
DeviceDevice · Authorizations Verified Status Regime Registry Class
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Abbott Quickstart Amylase, #5AXX Ref K920583
Active Regimes: 510(k) Registry: 510(k) ClassClass:IILactate Dehydrogenase (Ld) Test Item #65418 Ref K924703
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISystemate Ck-Mb(Nac-Activated) Item No. 67205 Ref K852483
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEmds Total Ck Test Pack-#67670/95 Ref K855056
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbbott Quickstart Albumin Test (Albg) Item #5A37 Ref K913920
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Prothrombin Time Pt Item No. 16628 Ref K875062
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbbott Quickstart Gamma-Glutamytransferase Test Ref K913024
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAbbott Quickstart Sgpt, Item Number 5A43 Ref K914464
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Ultra Chem Enzymatic Triglyceride Ref K842211
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAmylase Test (Amyl) Item Number: 65653 Ref K884382
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISystemate T-Bili 67212 Ref K843328
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Emit(R) Amikacin (Amik) No. 16645 Ref K873426
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBicarbonate Test Item Number: SR1006 Ref K890305
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIUrea Nitrogen Test (Bun) Item Number: SR1022 Ref K884987
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Calcium (Ca), Item No. 67528/93 Ref K870170
Active Regimes: 510(k) Registry: 510(k) ClassClass:IITriglycerides Ref K924710
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAbbott Quick Start Glucose (Glue) Item# 5A15 Ref K912808
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAspartate Aminotransferase (Ast) Test Ref K935181
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICalcium Test Item Number 65409 Ref K932158
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIUrea Nitrogen Test Ref K903334
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICalcium Test Item Number: SR1009 Ref K884986
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIGlucose-Hk Test (Gluc-Hk) Item #65665 Ref K884736
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIRevised Magnesium Test Item Number: SR1019 Ref K890798
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAbbott Quickstart Magnesium Test, Item #5A32 Ref K913764
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEasy-Test Magnesium (Mg) Item No. 16XXX Ref K870553
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEasy-Test Hdl Cholesterol Item Number 16683 Ref K874397
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEmds Total Bilirubin (Tbil) Testpacks, #67675/95 Ref K872512
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEmds(Tm) Creatinine(Crea) Testpacks, #67669/95 Ref K863738
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICreatinine Test (Crea) Item #65663 Ref K884734
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISystemate Alkaline Phosphatase(Epos Appl) #65483 Ref K910639
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Systemate Glucose 67216 Ref K843150
Active Regimes: 510(k) Registry: 510(k) ClassClass:IITotal Protein Test (Tp) Item #65670 Ref K884703
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISystemate Uricacid Test, Technicon Ra 1000 Ref K923765
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEasy-Test Iron (Iron) Item No. 16686 Ref K892863
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISystemate Total Bilirubin Catalog No. 65407 Ref K895118
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEmds Magnesium (Mg) Test Ref K935183
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Easy-Test Triglyceride (Trig) Number 16608 Ref K870408
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAlbumin Test Ref K923959
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEmds Chemistry Calibrators, Levels I & Ii Ref K860765
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Total Protein (Tp) Item Number: 19011 Ref K874476
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISystemate Bicarbonate Olympus Bicarbonate Ref K903409
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEmds Enzyme Verifier, Levels I & Ii Ref K860764
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISystemate D-Bili 67213 Ref K843329
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbbott Quickstart Sgot, Item Number: 5A42 Ref K914463
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbbott Quickstart Alanine Aminotransfer Ref K913846
Active Regimes: 510(k) Registry: 510(k) ClassClass:ILactate Dehydrogenase Test (Ld) Item No. 65668 Ref K884548
Active Regimes: 510(k) Registry: 510(k) ClassClass:II
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