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 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
Cleared May 23, 1990
COULTER CK (CREATINE KINASE) REAGENT
K901267
Coulter Corp.
Chemistry · 68d
Cleared Nov 08, 1989
CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS
K894715
Catachem, Inc.
Chemistry · 106d
Cleared Jul 20, 1989
REP(TM) CK-2 STAT KIT, CAT. NO. 3074
K893007
Helena Laboratories
Chemistry · 87d
Cleared Jul 20, 1989
BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME
K893269
Beckman Instruments, Inc.
Chemistry · 79d
Cleared May 22, 1989
ROCHE(R) CARDIOSCREEN-CK
K891462
Roche Diagnostic Systems, Inc.
Chemistry · 68d
Cleared May 09, 1989
CK-NAC 2-VIAL REAGENT W/SUBSTRATE START
K891470
Trace Scientific , Ltd.
Chemistry · 55d
Cleared Feb 27, 1989
ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC
K890540
Abbott Laboratories
Chemistry · 24d
Cleared Feb 10, 1989
CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673
K884547
Em Diagnostic Systems, Inc.
Chemistry · 102d
Cleared Feb 02, 1989
CREATINE KINASE TEST (CK) ITEM NUMBER: 65661
K884546
Em Diagnostic Systems, Inc.
Chemistry · 94d
Cleared Oct 13, 1988
VISION CREATINE KINASE
K883946
Abbott Laboratories
Chemistry · 24d
Cleared Sep 13, 1988
DURAZYME(R) CPK
K883504
American Monitor Corp.
Chemistry · 27d
Cleared Nov 05, 1987
WAKO(TM) AUTOKIT CK-NAC
K873201
Wako Chemicals USA, Inc.
Chemistry · 84d
Cleared Nov 05, 1987
TITAN GEL REP CPK-12 HV
K874146
Helena Laboratories
Chemistry · 23d