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Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

Regulation 862.1215

0510(k)s in 12 months (123 all time)
1recalls in 12 months (10 all time)
8recalls that name a 510(k)
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Top companies in CGS

Company510(k)sRecalls
Em Diagnostic Systems, Inc.140
Abbott Laboratories43
Helena Laboratories70
Siemens Healthcare Diagnostics34
Harleco60
Randox Laboratories, Ltd.31
Diagnostic Chemicals , Ltd.30
Emd Chemicals, Inc.30
Reagents Applications, Inc.30
Sclavo, Inc.30
Decided510(k)Device and applicantCode
Apr 1, 1982K820644RAICHEM TM CREATINE KINASE REAGENT
Reagents Applications, Inc.
CGS
Oct 2, 1981K812593ULTRA ZYME PLUS CK-1 #64978, 65027 & 28
Harleco
CGS
Jun 25, 1981K811576CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)
Harleco
CGS
Jun 25, 1981K811574CARDIOZYME PLUS CK-TOTAL ITEM #65046
Harleco
CGS
May 29, 1981K810853CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT
The Upjohn Co.
CGS
Jan 16, 1981K803301CREATINE KINASE REAGENT
Gilford Diagnostics
CGS
Jul 14, 1980K801299COBAS CK-NAC REAGENT
Roche Analytical Instruments, Inc.
CGS
Feb 13, 1980K800127CENTRIFICHEM CK
Union Carbide Corp.
CGS
Dec 27, 1979K792477CHEM-STRATE CK-NAC
General Diagnostics
CGS
Dec 4, 1978K781859REAGENT SYSTEM, NO 46-OV FOR CPK
Sigma Chemical Co.
CGS
Nov 3, 1978K781719CPK REAGENT SET, NAD REDUCTION
Medical Analysis Systems, Inc.
CGS
Aug 14, 1978K781149CPK-L TUBE
Bd Becton Dickinson Vacutainer Systems Preanalytic
CGS
Apr 5, 1978K780311DIAGNOSTIC KIT, CPK
Sclavo, Inc.
CGS
Mar 9, 1978K780100ULTRAZYME PLUS CK-1
Harleco
CGS
Feb 13, 1978K780070CPK REAGENT SET
Medical Analysis Systems, Inc.
CGS
Jan 31, 1978K772352STAC SYSTEM - ADDITIONAL ANALYTES
Technicon Instruments Corp.
CGS
Jan 5, 1978K772258CLINICARD CK-II
Harleco
CGS
Nov 3, 1977K771849CPK COLOR TEST KIT
Mallinckrodt Critical Care
CGS
Sep 2, 1977K771389CK-1 ULTRAZYME PLUS
Harleco
CGS
Aug 22, 1977K771441MULTISTAT III CPK TEST
Instrumentation Laboratory CO
CGS
Jul 1, 1977K770694CPK ULTRAZYME PLUS
Harleco Diagnostics
CGS
Apr 5, 1977K770319REAGENT CPK, ENZYME
Icn Pharmaceuticals, Inc.
CGS
Jan 5, 1977K761344DYNAZYME-II TM CK-230 KIT
J.T. Baker Chemical Co.
CGS

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