CGS · Class II · 21 CFR 862.1215

FDA Product Code CGS: Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes

Leading manufacturers include Em Diagnostic Systems, Inc., Helena Laboratories and Harleco.

123
Total
123
Cleared
65d
Avg days
1977
Since
123 devices
25–48 of 123
Cleared Dec 26, 1995
CK-MB (NAC-ACT)
K951223
Randox Laboratories, Ltd.
Chemistry · 281d
Cleared Aug 11, 1995
CREATINE KINASE REAGENT SYSTEM
K952745
Medical Diagnostic Technologies, Inc.
Chemistry · 56d
Cleared Aug 04, 1995
IL TEST CK-MB
K952646
Instrumentation Laboratory CO
Chemistry · 56d
Cleared Mar 03, 1995
CK QVET
K950177
Prisma Systems
Chemistry · 45d
Cleared Aug 24, 1994
CK-MB ASSAY, CATALOGUE NUMBER 317-10
K942773
Diagnostic Chemicals , Ltd.
Chemistry · 72d
Cleared Jan 11, 1994
CREATINE KINASE-MB (CK-MB) REAGENT SET
K935463
Pointe Scientific, Inc.,
Chemistry · 60d
Cleared Sep 08, 1993
OPUS TOTAL CK
K933675
Pb Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Jul 27, 1993
CREATINE KINASE TEST
K931889
Em Diagnostic Systems, Inc.
Chemistry · 103d
Cleared Jun 15, 1993
KING DIAGNOSTICS CK REAGENT
K931326
King Diagnostics, Inc.
Chemistry · 91d
Cleared May 11, 1993
SYNERMED CREATINE KINASE REAGENT KIT
K930932
Synermed, Inc.
Chemistry · 77d
Cleared Mar 29, 1993
CREATINE KINASE (CK) REAGENT SET
K930660
Pointe Scientific, Inc.,
Chemistry · 48d
Cleared Jan 04, 1993
OLYMPUS CREATINE KINASE REAGENT
K924832
Olympus Corp.
Chemistry · 101d
Cleared Dec 28, 1992
REP E-Z CK-30 ISOENZYME KIT
K925801
Helena Laboratories
Chemistry · 42d
Cleared Oct 15, 1992
CK-NAC ACTIVATED KIT
K923511
Randox Laboratories, Ltd.
Chemistry · 92d
Cleared Oct 13, 1992
CREATINE KINASE (CK) TEST ITEM #65411
K924704
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Jul 13, 1992
OLYMPUS CREATINE KINASE REAGENT
K922459
Olympus Corp.
Chemistry · 48d
Cleared Dec 13, 1991
CREATINE KINASE MB TEST ITEM NUMBER 5A46
K914361
Em Diagnostic Systems, Inc.
Chemistry · 73d
Cleared Sep 25, 1991
RAICHEM(TM) CREATINE KINASE-MB REAGENT
K913398
Reagents Applications, Inc.
Chemistry · 57d
Cleared Dec 20, 1990
RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV
K905084
Reagents Applications, Inc.
Chemistry · 36d
Cleared Dec 11, 1990
AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116
K904004
Amresco, Inc.
Chemistry · 104d
Cleared Oct 04, 1990
CREATINE PHOSPHOKINASE
K903775
Amresco, Inc.
Chemistry · 45d
Cleared Sep 27, 1990
REFLOTRON CREATINE KINASE TEST TABS
K904102
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Aug 17, 1990
CREATINE KINASE TEST (CK) ITEM NUMBER 65411
K903333
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Jul 10, 1990
CREATINE KINASE-MB TEST (MB-DS) ITEM #67655
K902483
Em Diagnostic Systems, Inc.
Chemistry · 35d