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 Abbott Laboratories.

123
Total
123
Cleared
65d
Avg days
1977
Since
123 devices
25–48 of 123
Cleared Apr 24, 1986
EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK
K861061
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Apr 07, 1986
CREATINE KINASE, N-ACETYL-L-CYSTIENE
K860669
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Jan 22, 1986
EMDS TOTAL CK TEST PACK-#67670/95
K855056
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Oct 22, 1985
EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE
K852392
Helena Laboratories
Chemistry · 139d
Cleared Jul 12, 1985
SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205
K852483
Em Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Sep 28, 1984
TITAN GEL ISO DOT CPK PROCEDURE
K842755
Helena Laboratories
Chemistry · 74d
Cleared Sep 07, 1984
SYSTEMATE CK-TOTAL - 67206
K843271
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Jun 25, 1984
SIGMA PROCEDURE 47-UV
K842013
Sigma Chemical Co.
Chemistry · 39d
Cleared Feb 27, 1984
CK-NAC REAGENT
K834502
Roche Diagnostic Systems, Inc.
Chemistry · 68d
Cleared May 21, 1982
LIQUID-STAT LIQUID ENZYME REAGENT
K821240
Beckman Instruments, Inc.
Chemistry · 22d
Cleared Dec 04, 1978
REAGENT SYSTEM, NO 46-OV FOR CPK
K781859
Sigma Chemical Co.
Chemistry · 28d
Cleared Aug 14, 1978
CPK-L TUBE
K781149
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 34d
Cleared Aug 22, 1977
MULTISTAT III CPK TEST
K771441
Instrumentation Laboratory CO
Chemistry · 21d