CFJ · Class II · 21 CFR 862.1440

FDA Product Code CFJ: Nad Reduction/nadh Oxidation, Lactate Dehydrogenase

Leading manufacturers include Em Diagnostic Systems, Inc., J.T. Baker Chemical Co. and Harleco.

111
Total
111
Cleared
44d
Avg days
1976
Since
111 devices
97–111 of 111
Cleared Feb 14, 1978
ULTRAZYME PLUS LDH
K780101
Harleco
Chemistry · 25d
Cleared Feb 01, 1978
LACTATE DEHYDROGENASE
K780041
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Nov 22, 1977
LACTATE DEHYDROGENASE
K771836
Gamma Enterprises, Inc.
Chemistry · 62d
Cleared Nov 15, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH
K772028
Harleco
Chemistry · 19d
Cleared Sep 02, 1977
MULTISTAT III LACTIC DEHYDROGENASE
K771465
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Jul 11, 1977
ULTRAZYME PLUS, LDH
K770818
Harleco
Chemistry · 68d
Cleared Jun 17, 1977
LDH ULTRAZYME PLUS
K770613
Harleco Diagnostics
Chemistry · 78d
Cleared Apr 05, 1977
REAGENT LDH-L, ENZYME
K770313
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Feb 23, 1977
LDH-L TEST
K770267
Sclavo, Inc.
Chemistry · 12d
Cleared Jan 05, 1977
DYNAZYME-II TM LDH-L 340 KIT
K761343
J.T. Baker Chemical Co.
Chemistry · 8d
Cleared Nov 02, 1976
LDH SUBSTRATE
K760412
J.T. Baker Chemical Co.
Chemistry · 85d
Cleared Nov 01, 1976
REAGENT, LACTATE DEHYDROGENASE
K760476
Simmler & Son, Inc.
Chemistry · 76d
Cleared Oct 29, 1976
AMP BUFFER
K760410
J.T. Baker Chemical Co.
Chemistry · 81d
Cleared Oct 29, 1976
NAD (SPOONPAK CONTAINER)
K760411
J.T. Baker Chemical Co.
Chemistry · 81d
Cleared Oct 27, 1976
TEST, LACTATE DEHYDROGENASE
K760345
Princeton Biomedix
Chemistry · 86d