CIT · Class II · 21 CFR 862.1100

FDA Product Code CIT: Nadh Oxidation/nad Reduction, Ast/sgot

Leading manufacturers include Em Diagnostic Systems, Inc., Abbott Laboratories and Roche Diagnostic Systems, Inc..

139
Total
139
Cleared
61d
Avg days
1976
Since
139 devices
121–139 of 139
Cleared May 12, 1978
AST(GOT) UNI-UV, SGOT
K780463
Sclavo, Inc.
Chemistry · 50d
Cleared May 03, 1978
SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE
K780505
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared Apr 24, 1978
SGOT/AST REAGENT SYSTEM
K780443
American Monitor Corp.
Chemistry · 35d
Cleared Feb 13, 1978
ULTRAZYME PLUS GOT
K780103
Harleco
Chemistry · 24d
Cleared Jan 31, 1978
ASPARTATE TRANSAMINASE
K780039
Beckman Instruments, Inc.
Chemistry · 22d
Cleared Jan 30, 1978
SERUM GLUTAMIC OXALOACETIC TRANSAMINASE
K780013
Macomb Chemical Co.
Chemistry · 27d
Cleared Nov 15, 1977
GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT
K772029
Harleco
Chemistry · 19d
Cleared Nov 03, 1977
DYNA ZYME II GOT 340
K771153
J.T. Baker Chemical Co.
Chemistry · 129d
Cleared Apr 05, 1977
REAGENT GOT, ENZYME
K770318
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Aug 03, 1976
NDC#12739-0011-1 C-ZYME GOT
K760193
Coulter Electronics, Inc.
Chemistry · 28d
Cleared Jul 26, 1976
COLORIMETRIC DETERMINATION (SGOT/SGPT)
K760010
The Dow Chemical Co.
Chemistry · 46d