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
25–48 of 139
Cleared Aug 29, 1986
SYSTEMATE (TM) ALANINE TRANSFERASE (ALT)
K863094
Em Diagnostic Systems, Inc.
Chemistry · 16d
Cleared May 05, 1986
VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM
K860465
Abbott Laboratories
Chemistry · 88d
Cleared Jan 14, 1986
VISION SGOT (AST)
K854982
Abbott Laboratories
Chemistry · 33d
Cleared Nov 05, 1984
ROCHE REAGENT FOR AST
K843109
Roche Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Sep 20, 1984
SYSTEMATE GOT 67208
K843333
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Aug 12, 1984
SIGMA 58-UV ASPARTATE AMINOTRANSFERAS
K842411
Sigma Chemical Co.
Chemistry · 54d
Cleared Jun 02, 1982
BECKMAN LIQUID-STAT AST-UV LIQUID
K821433
Beckman Instruments, Inc.
Chemistry · 21d
Cleared Feb 23, 1981
AST (UV) TEST
K810390
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared May 18, 1978
SINGLE VIAL 10 SGOT-TRIS
K780634
Boehringer Mannheim Corp.
Toxicology · 31d
Cleared Jan 31, 1978
ASPARTATE TRANSAMINASE
K780039
Beckman Instruments, Inc.
Chemistry · 22d