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
73–96 of 139
Cleared Nov 28, 1986
EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95
K863963
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Sep 26, 1986
AST/GOT PROCEDURE
K863257
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Aug 29, 1986
SYSTEMATE (TM) ALANINE TRANSFERASE (ALT)
K863094
Em Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Aug 12, 1986
MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT
K862832
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 18d
Cleared May 29, 1986
AST/GOT PROCEDURE
K861656
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 05, 1986
VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM
K860465
Abbott Laboratories
Chemistry · 88d
Cleared Apr 28, 1986
AST REAGENT CARTRIDGE
K861283
Hi Chem, Inc.
Chemistry · 21d
Cleared Apr 07, 1986
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT
K860725
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 03, 1986
ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET
K860667
Sterling Diagnostics, Inc.
Chemistry · 38d
Cleared Jan 14, 1986
VISION SGOT (AST)
K854982
Abbott Laboratories
Chemistry · 33d
Cleared Nov 25, 1985
AST(OPTIMIZED) REAGENT
K854503
Sigma Diagnostics, Inc.
Chemistry · 13d
Cleared Jul 22, 1985
SGOT/ALT REAGENT
K852783
Advanced Biomedical Methods, Inc.
Chemistry · 21d
Cleared Jun 03, 1985
AST ASPARTATE AMINOTRANSFERASE REAGENT
K851994
Alpkem Corp.
Chemistry · 27d
Cleared May 20, 1985
AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE
K851865
Amresco, Inc.
Chemistry · 21d
Cleared Apr 29, 1985
GEMENI AST-LTS REAGENTS
K851267
Electro-Nucleonics Laboratories, Inc.
Chemistry · 31d
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 Jul 18, 1984
ASPARTATE AMINOTRANSFERASE ASSAY KIT
K842245
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
Cleared May 01, 1984
SGOT-UV REAGENT SET
K841066
Medical Specialties, Inc.
Chemistry · 50d
Cleared Apr 04, 1984
ASPARTATE AMINOTRANSFERASE REAGENT
K840706
American Dade
Hematology · 47d
Cleared May 04, 1983
FLOW-PAC SGOT REAGENT
K830958
Amresco, Inc.
Chemistry · 40d
Cleared Jul 20, 1982
SGOT-UV REAGENT SET
K821208
Omega Medical Electronics
Chemistry · 84d
Cleared Jul 13, 1982
ULTRAZYME PLUS GOT
K821876
Harleco Diagnostics
Chemistry · 18d