Medical Device Manufacturer · US , Walker , MI

Em Diagnostic Systems, Inc.

288 submissions · 288 cleared · Since 1984
288
Total
288
Cleared
0
Denied

Em Diagnostic Systems, Inc. — FDA 510(k) Submissions

Em Diagnostic Systems, Inc. has submitted 288 FDA 510(k) premarket notifications since 1984, of which 288 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Diazo Colorimetry, Bilirubin, Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes, Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides, Alkaline Picrate, Colorimetry, Creatinine, Biuret (colorimetric), Total Protein . Use the specialty filter in the sidebar to narrow results.

288 devices
1–25 of 288
ASPARTATE AMINOTRANSFERASE (AST) TEST
K935181 · CIT Nadh Oxidation/nad... · Chemistry
Jan 1994 93d
ALANINE AMINOTRANSFERASE (ALT) TEST
K935180 · CKA Nadh Oxidation/nad... · Chemistry
Jan 1994 79d
EMDS PHOSPHOROUS (PHOS) TEST
K935178 · CEO Phosphomolybdate... · Chemistry
Dec 1993 52d
EMDS ALBUMIN (ALB) TEST
K935179 · CIX Bromcresol Green... · Chemistry
Dec 1993 52d
CHOLESTEROL (CHOL) TEST ITEM NO. 65410
K935136 · CHH Enzymatic... · Chemistry
Dec 1993 49d
TOTAL PROTEIN TEST (TPRO)
K935174 · CEK Biuret (colorimetric),... · Chemistry
Dec 1993 50d
LACTATE DEHYDROGENASE (LD)
K935175 · CFJ Nad Reduction/nadh... · Chemistry
Dec 1993 50d
IRON TEST
K935176 · JIY Photometric Method, Iron... · Chemistry
Dec 1993 50d
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
K935177 · JQB Kinetic Method,... · Chemistry
Dec 1993 51d
EMDS ALKANINE PHOSPHATASE (ALP) TEST
K935182 · CJE Nitrophenylphosphate,... · Chemistry
Dec 1993 43d
EMDS MAGNESIUM (MG) TEST
K935183 · JGJ Photometric Method,... · Chemistry
Dec 1993 43d
CALCIUM TEST ITEM NUMBER 65409
K932158 · CIC Cresolphthalein... · Chemistry
Sep 1993 146d
URIC ACID TEST ITEM NUMBER 65422
K932162 · CDO Acid, Uric, Uricase (u.v.) · Chemistry
Sep 1993 146d
SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406
K932159 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Sep 1993 140d
UREA NITROGEN TEST ITEM NUMBER 65408
K932161 · CDQ Urease And Glutamic... · Chemistry
Sep 1993 127d
TRIGLYCERIDES
K931891 · CDT Lipase... · Chemistry
Aug 1993 132d
ETHYLIDENE AMYL
K931582 · JFJ Catalytic Methods, Amylase · Chemistry
Aug 1993 141d
SILYL AMYL
K931583 · JFJ Catalytic Methods, Amylase · Chemistry
Aug 1993 141d
BICARBONATE
K931887 · KHS Enzymatic, Carbon-dioxide · Chemistry
Aug 1993 110d
TOTAL BILIRUBIN
K931888 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Jul 1993 103d
CREATINE KINASE TEST
K931889 · CGS Nad Reduction/nadh... · Chemistry
Jul 1993 103d
GLUCOSE-HK TEST
K931890 · CFR Hexokinase, Glucose · Chemistry
Jul 1993 98d
SYSTEMATE CREATININE TEST ITEM NUMBER 65413
K932160 · CGX Alkaline Picrate,... · Chemistry
Jul 1993 66d
IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R
K930166 · JIY Photometric Method, Iron... · Chemistry
Apr 1993 98d
SYSTEMATE PLUS CALIBRATOR
K925101 · JIX Calibrator, Multi-analyte... · Chemistry
Feb 1993 138d

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