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
97–120 of 123
Cleared Nov 03, 1977
CPK COLOR TEST KIT
K771849
Mallinckrodt Critical Care
Chemistry · 36d
Cleared Sep 02, 1977
CK-1 ULTRAZYME PLUS
K771389
Harleco
Chemistry · 37d
Cleared Aug 22, 1977
MULTISTAT III CPK TEST
K771441
Instrumentation Laboratory CO
Chemistry · 21d
Cleared Jan 05, 1977
DYNAZYME-II TM CK-230 KIT
K761344
J.T. Baker Chemical Co.
Chemistry · 8d