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

FDA 510(k) Cleared Nadh Oxidation/nad Reduction, Ast/sgot Devices (Product Code CIT)

139 devices
1–24 of 139
Cleared Mar 19, 2008
ACTIVATED ASPARTATE AMINOTRANSFERASE
K071525
Abbott Laboratories
Chemistry · 289d
Cleared Jul 30, 2007
COBAS C 111 ANALYZER
K071211
Roche Diagnostics
Chemistry · 90d
Cleared Jun 28, 2000
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
K001679
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
Cleared Dec 16, 1999
WAKO L-TYPE GOT TEST
K993468
Wako Chemicals USA, Inc.
Chemistry · 64d
Cleared Nov 09, 1999
BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)
K992136
Bayer Corp.
Chemistry · 138d
Cleared Sep 28, 1999
SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5
K992801
Sigma Diagnostics, Inc.
Chemistry · 40d
Cleared Sep 28, 1998
AST
K983131
Abbott Laboratories
Chemistry · 20d
Cleared Jun 29, 1998
AST/SGOT LIQUID REAGENT - KINETIC METHOD
K981650
Teco Diagnostics
Chemistry · 49d
Cleared Jun 29, 1998
AST
K981843
Abbott Laboratories
Chemistry · 34d
Cleared Apr 23, 1998
ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)
K981221
Abbott Laboratories
Chemistry · 20d
Cleared Apr 23, 1998
ASPARTATE AMINOTRANSFERASE (AST)
K981225
Abbott Laboratories
Chemistry · 20d
Cleared Mar 20, 1998
INFINITY AST REAGENT (PROCEDURE NO. 51)
K980666
Sigma Diagnostics, Inc.
Chemistry · 28d
Cleared Nov 13, 1997
ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30
K974001
Diagnostic Chemicals , Ltd.
Chemistry · 23d
Cleared May 23, 1996
AST INCORPORATING DST
K961114
Trace Scientific , Ltd.
Chemistry · 64d
Cleared Jan 25, 1996
ROCHE COBAS INTEGRA REAGENT CASSETTES
K954992
Roche Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Jan 05, 1996
ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV
K954839
Sigma Diagnostics, Inc.
Chemistry · 77d
Cleared Sep 29, 1995
ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM
K952743
Medical Diagnostic Technologies, Inc.
Chemistry · 105d
Cleared Aug 02, 1995
HICHEM AST REAGENT KIT
K951751
Hichem Diagnostics
Chemistry · 107d
Cleared May 02, 1994
LIQUID AST (SGOT)REAGENT SET
K941132
Pointe Scientific, Inc.,
Chemistry · 54d
Cleared Apr 25, 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE
K934413
Eastman Kodak Company
Chemistry · 227d
Cleared Jan 27, 1994
ASPARTATE AMINOTRANSFERASE (AST) TEST
K935181
Em Diagnostic Systems, Inc.
Chemistry · 93d
Cleared Nov 16, 1993
STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020
K932049
Stanbio Laboratory
Chemistry · 203d
Cleared Jan 26, 1993
OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT
K925155
Olympus Corp.
Chemistry · 105d
Cleared Jan 04, 1993
ROCHE REAGENT FOR AST
K924244
Roche Diagnostic Systems, Inc.
Chemistry · 133d

About Product Code CIT - Regulatory Context