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
49–72 of 123
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 Mar 16, 1989
IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)
K890609
Intl. Immunoassay Laboratories, Inc.
Chemistry · 37d
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
Cleared Nov 03, 1987
TITAN GEL REP CPK-30 HV
K874139
Helena Laboratories
Chemistry · 21d
Cleared Nov 03, 1987
TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED.
K874140
Helena Laboratories
Chemistry · 21d
Cleared Sep 16, 1987
UNIFAST CK-MB
K873134
Sclavo, Inc.
Chemistry · 37d
Cleared Mar 10, 1987
EASY-TEST CREATINE KINASE-MB (CK-MB) #16615
K870462
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Mar 06, 1987
EASY-TEST CREATINE KINASE (CK) NUMBER: 16614
K870461
Em Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Feb 06, 1987
CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE)
K864359
Trace Scientific , Ltd.
Chemistry · 95d
Cleared Jan 13, 1987
CREATINE PHOSPHOKINASE (CK)
K864744
Tech-Co, Inc.
Chemistry · 40d
Cleared Oct 03, 1986
CREATINE PHOSPHOKINASE(CK) PROCEDURE
K863587
Data Medical Associates, Inc.
Chemistry · 18d
Cleared Jun 05, 1986
CREATINE PHROSPHOKINASE (CK) PROCEDURE
K861665
Data Medical Associates, Inc.
Chemistry · 36d
Cleared May 29, 1986
CK REAGENT CARTRIDGE (PRODUCT NO. 88213)
K861879
Hi Chem, Inc.
Chemistry · 14d