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 Sep 20, 2010
AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-
K093883
Seppim S.A.S.
Chemistry · 276d
Cleared Dec 04, 2008
ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
K080485
Diasys Diagnostics Systems GmbH
Chemistry · 286d
Cleared Mar 19, 2008
ACTIVATED ASPARTATE AMINOTRANSFERASE
K071525
Abbott Laboratories
Chemistry · 289d
Cleared Oct 03, 2007
AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
K071580
Thermofisher Scientific OY
Chemistry · 117d
Cleared Jul 30, 2007
COBAS C 111 ANALYZER
K071211
Roche Diagnostics
Chemistry · 90d
Cleared Aug 08, 2006
HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K060318
Horiba Abx
Chemistry · 181d
Cleared Dec 09, 2002
WIENER LAB GOT (AST) UV AA LIQUIDA
K023551
Wiener Laboratories Saic
Chemistry · 48d
Cleared Dec 21, 2001
AST (SGOT)
K013698
Jas Diagnostics, Inc.
Chemistry · 44d
Cleared Nov 27, 2001
WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR.
K013145
Wiener Laboratories Saic
Chemistry · 68d
Cleared Apr 09, 2001
ATAC PAK AST REAGENT KIT
K010488
Elan Holdings, Inc.
Chemistry · 48d
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 Jun 30, 1999
AST/SGOT
K991663
A.P. Total Care, Inc.
Chemistry · 47d
Cleared Mar 16, 1999
CARESIDE AST
K990009
Careside, Inc.
Chemistry · 71d
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 26, 1998
N-ASSAY L AST/GOT
K980902
Crestat Diagnostics, Inc.
Chemistry · 16d
Cleared Mar 20, 1998
INFINITY AST REAGENT (PROCEDURE NO. 51)
K980666
Sigma Diagnostics, Inc.
Chemistry · 28d
Cleared Jan 30, 1998
AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K980030
Trace America, Inc.
Chemistry · 25d

About Product Code CIT - Regulatory Context