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:I
Systemate Got 67208 Ref K843333
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIGamma Gultamyl Transferase Test Ref K922947
Active Regimes: 510(k) Registry: 510(k) ClassClass:IGlucose-Hk Test (Glu-Hk) Item #65415 Ref K894483
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIPregnancy Card Test Ref K852066
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAdditional Allergens For Ige Fast-Plus Test Ref K880003
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISystemate Albumin Ref K843108
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISystemate Bun Hem No. 67221 Ref K843326
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOlympus Inorganic Phosphorus Ref K903696
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISystemate Phosphorus 67217 Ref K843330
Active Regimes: 510(k) Registry: 510(k) ClassClass:IUric Acid Test Item Number 65422 Ref K894287
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAspartate Aminotransferase Test Ref K903197
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbbott Quickstart Ld-1, #5A30 Ref K914261
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Hemoglobin (Hgb) Item #16685 Ref K872653
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISystemate Uric Acid, Hem 67220 Ref K843325
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEasy-Test Carbamazepine Item No. 67---/95 Ref K864553
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Cholesterol Test Ref K923733
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISystemate Ck-Total - 67206 Ref K843271
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEmds Lidocaine Calibrator Item No. 67XXX/95 Ref K881337
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbbott Quickstart Direct Bilirubin (Dbil) #5A20 Ref K913466
Active Regimes: 510(k) Registry: 510(k) ClassClass:IILactate Dehydrogenase (Ld) Ref K935175
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Uric Acid (Uric) #16606 Ref K870868
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Bicarbonate Test Item Number: 65412 Ref K894509
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAlkaline Phosphatase (Alk P) Testpack #67690/95 Ref K873681
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISystemate Calcium (Epos Application) #65409 Ref K905659
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Ammonia (Amon) Item No. 16695 Ref K872110
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEasy-Test Emit* Theophylline(Theo) Item 67533/93 Ref K862350
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Uric Acid (Uric), #67516/93 Ref K860916
Active Regimes: 510(k) Registry: 510(k) ClassClass:IBicarbonate Ref K924711
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISyste Mate Iron, Hem No. 67224 Ref K845020
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISystemate Cholesterol 67222 Ref K843327
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEasy-Test Creatine Kinase-Mb (Ck-Mb) #16615 Ref K870462
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEmds(Tm) Elevated Lipid Calibrator #67626/95 Ref K862703
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Easy St Analyzer System Ref K872813
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEmds Phosphorous (Phos) Test Ref K935178
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEasy-Test Emit N-Acetylprocainamide Napa #16649 Ref K873349
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICreatine Kinase Test (Ck) Item Number: 65661 Ref K884546
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISystemate 2GT - 67207 Ref K843268
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAlbumin Test (Alb) Item #65650 Ref K884705
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEmds(Tm) Cerebrospinal Fluid Protein, #67668/95 Ref K901083
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Systemate Plus Calibrator Ref K925101
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIChloride Standards Item #SR1041 Ref K891999
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Alcohol (Alc), Item No. 67515/93 Ref K864894
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEmit Quinidine Calibrator Item No. 67631/93 Ref K870247
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISystemate(Tm) Total Bilirubin Catalog No. 654XX Ref K897176
Active Regimes: 510(k) Registry: 510(k) ClassClass:II
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