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
Cholesterol Test Item Number: SR1011 Ref K885023
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISystemate Albumin (Epos Application) #65401 Ref K905660
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAlkaline Phosphatase Test (Alp) Item No. 65651 Ref K884549
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIron Test Ref K935176
Active Regimes: 510(k) Registry: 510(k) ClassClass:IConjugated Bilirubin (Cbil) Item No. 67684/95 Ref K873551
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIUni Pak 500 Analyzer + Chemistry Reagent Item Ref K852481
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEmds N-Acetylprocainamide Calibrator #67635/95 Ref K874101
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISystemate A Amylase Hem 67204 Ref K843645
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Easy-Test Alanine Aminotransferase (Alat) #19017 Ref K874586
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Easy-Test (Che) Reagent, Item No. 67522/93 Ref K860641
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEmds Uric Acid (Urc A) Testpack, Item #67664/95 Ref K863660
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEasy-Test Creatine Kinase (Ck) Number: 16614 Ref K870461
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICerebrospinal Fluid Protein Testpack, #67668/95 Ref K863478
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISilyl Amyl Ref K931583
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICreatine Kinase Test (Ck) Item Number 65411 Ref K903333
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEmds Gamma-Glutamyl Transferase (Ggt) 67680/95 Ref K872322
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEthylidene Amyl Ref K931582
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISystemate Creatinine Test Item Number 65413 Ref K932160
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Magnesium Test Item Number: SR1019 Ref K885022
Active Regimes: 510(k) Registry: 510(k) ClassClass:IAspartate Aminotransferase Test Item No. 65654 Ref K884377
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Emds Total Protein (Tp), Item Number 65420 Ref K893915
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Abbott Quickstart Total Protein Test Item# 5A13 Ref K912810
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Abbott Quickstart Asparate Aminotransferase Test Ref K914068
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIOlympus Direct Bilirubin Ref K897175
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIMagnesium Test Item Number: 65419 Ref K894508
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEasy-Test (Ggt) Reagent, Item No. 67526/93 Ref K860640
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISystemate Creatinine Test Ref K923203
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIQuickstart Urea Nitrogen Ref K914903
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbbott Quickstart Tiglycerides Reagent Ref K915732
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEasy-Test Partial Thromboplastin Time Ptt #16629 Ref K884702
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Amylase (Amyl), Item Number 19019 Ref K874705
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbbott Quickstart Triglycerides Reagents, #5A33 Ref K914018
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEmds(Tm) Alcohol Testpacks, #67691/95 Ref K863419
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Chek (Instrum. Check) & Emds Abs Test Ref K861221
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Easy-Test Urea (Bun) Reagent Ref K860135
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:I
Lactate Dehydrogenase Test (Ld) Item #65418 Ref K894482
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIUrea Nitrogen Test (Bun) Item #65408 Ref K894378
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbbott Qluickstart Iron Test, Item #5A29 Ref K913705
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISystemate Creatinine Test (Crea) #65413 Ref K895022
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Gamma-Glutamyl Transferase (Ggt) 16616 Ref K872320
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEmds Cholesterol (Cho), Item Number 65410 Ref K893916
Active Regimes: 510(k) Registry: 510(k) ClassClass:IUrea Nitrogen Test Ref K925002
Active Regimes: 510(k) Registry: 510(k) ClassClass:II
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