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
97–120 of 139
Cleared Jun 02, 1982
BECKMAN LIQUID-STAT AST-UV LIQUID
K821433
Beckman Instruments, Inc.
Chemistry · 21d
Cleared Jun 01, 1982
ULTRAZYME PLUS GOT, #64953,65033&65034
K821467
Emd Chemicals, Inc.
Chemistry · 14d
Cleared Feb 18, 1982
RAICHEM GOT (AST) REAGENT
K820270
Reagents Applications, Inc.
Chemistry · 16d
Cleared Dec 22, 1981
AST(SGOT) IN VITRO DIAG. REAGENT SET
K813405
Pointe Scientific, Inc.,
Chemistry · 15d
Cleared Sep 24, 1981
ULTRA ZYME PLUS GOT #64953, 65033 & 34
K812592
Harleco
Chemistry · 13d
Cleared Apr 17, 1981
GOT ISOENZYME ASSAY EIKEN KIT
K802447
Syn-Kit, Inc.
Chemistry · 191d
Cleared Mar 31, 1981
AST-UV (PLP-ACTIVATED) DETERMINATION
K810727
The Dow Chemical Co.
Chemistry · 14d
Cleared Feb 23, 1981
AST (UV) TEST
K810390
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Jan 09, 1981
CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT
K803216
Union Carbide Corp.
Chemistry · 22d
Cleared Sep 16, 1980
DATA-ZYME AST(GOT) PROCEDURE
K801856
Data Medical Associates, Inc.
Chemistry · 43d
Cleared May 28, 1980
REAGENT FOR DETERM. GLUTAMIC-OXALOACETIC
K800688
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared Apr 10, 1980
CENTRIFI CHEM AST/SGOT
K800641
Union Carbide Corp.
Chemistry · 17d
Cleared Feb 13, 1980
DURAZYME GOT/AST
K800116
American Monitor Corp.
Chemistry · 26d
Cleared Feb 05, 1980
ASI REAGENT
K800065
Gilford Diagnostics
Chemistry · 25d
Cleared Nov 27, 1979
DURAZYME GOT/AST
K792208
American Monitor Corp.
Chemistry · 25d
Cleared Sep 24, 1979
NADH OXIDATION, AST/SGOT
K791679
American Monitor Corp.
Chemistry · 27d
Cleared Jul 24, 1979
PLUS CHEM S.C.E. REAGENT
K791080
Smithkline Diagnostics, Inc.
Chemistry · 42d
Cleared Jul 17, 1979
SPIN CHEM REAGENT, DETERMINATION OF AST
K791082
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared May 03, 1979
COULTER ACCU-ZYME II GOT REAGENT
K790483
Coulter Electronics, Inc.
Chemistry · 55d
Cleared Feb 26, 1979
SERUM, GLUTAMIC-OXALOACETIC
K790017
Fisher Scientific Co., LLC
Chemistry · 54d
Cleared Jan 03, 1979
AST
K781784
Gilford Diagnostics
Chemistry · 76d
Cleared Nov 03, 1978
REAGENT SET, U.V. ENZMATIC KINETIC, SGOT
K781725
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Jul 27, 1978
(AST) OR (ALT) UV DETERM. PHY. PHOS.
K781020
The Dow Chemical Co.
Chemistry · 42d
Cleared May 18, 1978
SINGLE VIAL 10 SGOT-TRIS
K780634
Boehringer Mannheim Corp.
Toxicology · 31d