FDA 510(k) Applications for Medical Device Product Code "CIT"
(Nadh Oxidation/Nad Reduction, Ast/Sgot)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K991663 | A.P. TOTAL CARE, INC. | AST/SGOT | 06/30/1999 |
| K071525 | ABBOTT LABORATORIES | ACTIVATED ASPARTATE AMINOTRANSFERASE | 03/19/2008 |
| K981225 | ABBOTT LABORATORIES | ASPARTATE AMINOTRANSFERASE (AST) | 04/23/1998 |
| K981221 | ABBOTT LABORATORIES | ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) | 04/23/1998 |
| K983131 | ABBOTT LABORATORIES | AST | 09/28/1998 |
| K981843 | ABBOTT LABORATORIES | AST | 06/29/1998 |
| K992136 | BAYER CORP. | BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) | 11/09/1999 |
| K990009 | CARESIDE, INC. | CARESIDE AST | 03/16/1999 |
| K971344 | CAROLINA LIQUID CHEMISTRIES CORP. | AST OR SGOT | 04/21/1997 |
| K980902 | CRESTAT DIAGNOSTICS, INC. | N-ASSAY L AST/GOT | 03/26/1998 |
| K965126 | DERMA MEDIA LAB., INC. | AST/SGOT | 01/17/1997 |
| K974001 | DIAGNOSTIC CHEMICALS LTD. | ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30 | 11/13/1997 |
| K080485 | DIASYS DIAGNOSTICS SYSTEMS GMBH | ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS | 12/04/2008 |
| K010488 | ELAN HOLDINGS, INC. | ATAC PAK AST REAGENT KIT | 04/09/2001 |
| K060318 | HORIBA ABX | HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | 08/08/2006 |
| K013698 | JAS Diagnostics, Inc. | AST (SGOT) | 12/21/2001 |
| K001679 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 | 06/28/2000 |
| K954992 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE COBAS INTEGRA REAGENT CASSETTES | 01/25/1996 |
| K071211 | Roche Diagnostics | COBAS C 111 ANALYZER | 07/30/2007 |
| K093883 | SEPPIM S.A.S. | 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- | 09/20/2010 |
| K954839 | SIGMA DIAGNOSTICS, INC. | ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV | 01/05/1996 |
| K980666 | SIGMA DIAGNOSTICS, INC. | INFINITY AST REAGENT (PROCEDURE NO. 51) | 03/20/1998 |
| K992801 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 | 09/28/1999 |
| K981650 | TECO DIAGNOSTICS | AST/SGOT LIQUID REAGENT - KINETIC METHOD | 06/29/1998 |
| K071580 | THERMO FISHER SCIENTIFIC OY | AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL | 10/03/2007 |
| K980030 | TRACE AMERICA, INC. | AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | 01/30/1998 |
| K961114 | TRACE SCIENTIFIC LTD. | AST INCORPORATING DST | 05/23/1996 |
| K993468 | WAKO CHEMICALS, USA, INC. | WAKO L-TYPE GOT TEST | 12/16/1999 |
| K023551 | WIENER LABORATORIES S.A.I.C. | WIENER LAB GOT (AST) UV AA LIQUIDA | 12/09/2002 |
| K013145 | WIENER LABORATORIES S.A.I.C. | 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. | 11/27/2001 |
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