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
73–96 of 123
Cleared Apr 24, 1986
CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE
K860733
Trace Scientific , Ltd.
Chemistry · 57d
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 Feb 11, 1986
CPK REAGENT SET (COLORIMETRIC)
K860096
Sterling Diagnostics, Inc.
Chemistry · 32d
Cleared Jan 22, 1986
EMDS TOTAL CK TEST PACK-#67670/95
K855056
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Dec 04, 1985
CK(OPTIMIZED) REAGENT
K854501
Sigma Diagnostics, Inc.
Chemistry · 22d
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 May 30, 1985
CK-NAC REAGENT
K852000
Alpkem Corp.
Chemistry · 23d
Cleared Feb 07, 1985
ISOENZYME TEST CK-MB
K850212
Sclavo, Inc.
Chemistry · 23d
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 Jul 20, 1984
CREATINE KINASE ASSAY KIT NAC
K842508
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Jun 25, 1984
SIGMA PROCEDURE 47-UV
K842013
Sigma Chemical Co.
Chemistry · 39d
Cleared Apr 04, 1984
CREATINE KINASE MB REAGENT
K840783
American Dade
Chemistry · 49d
Cleared Feb 27, 1984
CK-NAC REAGENT
K834502
Roche Diagnostic Systems, Inc.
Chemistry · 68d
Cleared Jan 18, 1984
DURAZYME CPK
K833781
American Monitor Corp.
Chemistry · 82d
Cleared Sep 12, 1983
CREATINE KINASE REAGENT CK LTS
K831965
Electro-Nucleonics Laboratories, Inc.
Chemistry · 84d
Cleared Jun 22, 1983
PARAMAX CREATINE KINASE REAGENT
K831537
American Dade
Chemistry · 44d
Cleared Jul 14, 1982
ULTRAZYME PLUS CK-I
K821883
Harleco Diagnostics
Chemistry · 19d
Cleared Jun 03, 1982
ULTRAZYME PLUS CKI, #64978,65027&65028
K821473
Emd Chemicals, Inc.
Chemistry · 16d
Cleared Jun 02, 1982
CARDIOZYME PLUS CK-MB, #65045
K821464
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 01, 1982
ULTRAZYME PLUS CK-I, #64978,65027&65028
K821460
Emd Chemicals, Inc.
Chemistry · 14d
Cleared May 21, 1982
LIQUID-STAT LIQUID ENZYME REAGENT
K821240
Beckman Instruments, Inc.
Chemistry · 22d