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.

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What Em Diagnostic Systems, Inc. makes

Catalogue288

Iron(Irn) Testpack, Item No. 67659/95 Ref K870144

Systemate Direct Bilirubin Cat. No. 65406 Ref K932159

Abbott Quickstart Ldh, #5A31 Ref K914262

Emds Salicylate (Sal) Calibrator, No# 67641/93 Ref K872321

Emds(Tm) Aspartate Aminotransferase (Ast) 67657/95 Ref K863963

Easy-Test Emit(R) Ethosuximide (Eths) Item 16647 Ref K881607

Emds, Ck/Ck-Mb Verifier, Item Number 67---/95 Ref K861512

Easy-Test Lactic Dehydrogenase (Ldh) # 67527/95 Ref K863545

Emds(Tm) Triglyceride Testpacks #67674/95 Ref K862706

Total Bilirubin Ref K931888

Emds(Tm) Cholesterol Testpack, # 67685/95 Ref K862707

Phosphorus Test (Phos) Item #65666 Ref K884735

Easy-Test Total Bilirubin (Tbil) Item No. 16604 Ref K872513

Emds(Tm) Magnesium Testpacks, #67671/95 Ref K863002

Creatine Kinase (Ck) Test Item #65411 Ref K924704

Olympus Urine Ph Calibrators Levels I And Ii Ref K905477

Creatine Kinase Mb Test Item Number 5A46 Ref K914361

Systemate Amylase (Amyl) Item Number 65404 Ref K903332

Easy-Test Alkaline Phosphatase (Alp) #19021 Ref K873635

Emds Triglyceride (Trig), Item Number 65421 Ref K893917

Cholesterol Test Item# 42374/93, 42322/R1 Ref K924508

Systemate Total Protein Test, Technicon Ra 1000 Ref K923267

Creatine Kinase, N-Acetyl-L-Cystiene Ref K860669

Easy-Test Potassium K Item Number 19XXX Ref K880339

Systemate Calcium Test Technicon Ra 1000 Ref K922953

Emds Urea Nitrogen (Bun) Testpacks Item #67654/95 Ref K870571

Neonatal Bilirubin(Nbil) Test Pack 67661/95 Ref K855079

Systemate Phosphorus Test Technicon Ra 1000 Ref K923764

Emds Glucose (Glu-Hk) Test, Item 65415 Ref K924572

Systemate Alkaline Phosphatase-67203 Ref K843270

Abbott Quickstart Phosphorus(Phos) Item #5A14 Ref K912809

Total Protein Test (Tpro) Ref K935174

Systemate Gpt 67209 Ref K843334

Systemate Total Protein (Epos Application) #65420 Ref K905661

Uric Acid Test (Uric) Item #65620 Ref K884704

Emds Cholesterol (Cho), Item Numbers 65410 Ref K900850

Creatine Kinase-Mb Test (Mb-Ds) Item #67655 Ref K902483

Total Bilirubin Catalog No. 65407 Ref K923083