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
73–96 of 111
Cleared Nov 22, 1978
LDH
K781775
Gilford Diagnostics
Chemistry · 40d
Cleared Nov 03, 1978
NAD REDUCTION METHOD, LACTATE PYRIVATE
K781724
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Oct 03, 1978
SINGLE VIAL LDH-L TRIS
K781538
Boehringer Mannheim Corp.
Chemistry · 25d
Cleared Apr 18, 1978
SINGLE VIAL LACTATE
K780563
Boehringer Mannheim Corp.
Hematology · 11d
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 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 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 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