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
Olympus Triglycerides Reagents #SR1021 Ref K885266
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISystemate Ggt (Epos Application) #65414 Ref K905662
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEasy-Test Albumin (Alb), Item No. 19039 Ref K873994
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEmds(Tm) Phosphorus (Phos) Testpacks, #67678/95 Ref K863718
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEmds Glucose (Gluc) Testpacks, No. 67697/95 Ref K884021
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICalcium Test Item Number: 65409 Ref K893778
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIGamma Glutamyl Transferase Test, Item: 65414/R1 Ref K893765
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEmds(Tm) Albumin Testpacks, #67652/95 Ref K863004
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIDirect Bilirubin Test Catalog No. SR1008 Ref K885285
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISystemate Creatinine (Epos Application) #65413 Ref K905658
Active Regimes: 510(k) Registry: 510(k) ClassClass:IITriglycerides Ref K931891
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEmds(Tm) Calcium Testpacks, #67687/95 Ref K863003
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEmds(Tm) Total Protein Testpacks, #67663/95 Ref K863005
Active Regimes: 510(k) Registry: 510(k) ClassClass:IITotal Bilirubin Test Catalog No. SR1007 Ref K885284
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Phosphorus (Phos) Item No. 16687 Ref K874153
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEasy-Test Primidone Item No. 67---/95 Ref K864554
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEmds Tibc Pretreatment Set Item No. 67612/93 Ref K871414
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISystemate Direct Bilirubin Catalog No. 65406 Ref K895119
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Cholesterol(Chol) Number 16607 Ref K870407
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEasy-Test Alkaline Phosphatase (Alp) Reagent Ref K860134
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISyste Mate Tibc Hem No. 67225 Ref K850128
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISystemate(Tm) Alkaline Phosphatase Item #65402 Ref K895250
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Easy-Test Emit Gentamicin (Gent) Item No. 16640 Ref K871329
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICholesterol (Chol) Test Item No. 65410 Ref K935136
Active Regimes: 510(k) Registry: 510(k) ClassClass:ICreatine Kinase Test Ref K931889
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIUrea Nitrogen Test Item Number 65408 Ref K932161
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIHdl Cholesterol Test Ref K885265
Active Regimes: 510(k) Registry: 510(k) ClassClass:ISystemate Uric Acid (Urca) Item Number 65422 Ref K903335
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEasy-Test Salicylate (Sal) #16691 Ref K873425
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIGlucose-Hk Test Ref K931890
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISystemate Triglyceride 67219 Ref K843106
Active Regimes: 510(k) Registry: 510(k) ClassClass:IEasy-Test Emit Procainamide (Proc) #16648 Ref K873350
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEmds Alkaline Phosphatase (Alp) Test Ref K924574
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Emit Phenytoin(Phtn) Item # 67535/93 Ref K862349
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIMicrospin Minicentrifuge Item No. 65204/94 Ref K852482
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAlanine Aminotransferase Test Item No. 65652 Ref K884376
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIon-Specific Electrode, Chloride Ref K860668
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAmylase Test Ref K923677
Active Regimes: 510(k) Registry: 510(k) ClassClass:IISystemate Total Protein 67218 Ref K843107
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Urea Nitrogen (Bun) Item Number: 19010 Ref K874477
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAmylase Test (Aml) Item Number: 65404 Ref K893751
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIChloride Test (Cl) Item #65659 Ref K884706
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Amlase (Amyl), #67521/93 Ref K860918
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEmds Theophylline Testpacks Item #67662/95 Ref K864041
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEasy-Test Quinidine Item No. 67---/95 Ref K864607
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEmds Tm Phenytoin (Ptn) Testpack, Item #67676/95 Ref K864925
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIEmds Amikacin Calibrator Item No. 67633/95 Ref K873436
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAbbott Quickstart Cholesterol Test Ref K913565
Active Regimes: 510(k) Registry: 510(k) ClassClass:I
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