Product code CIT
- Device name
- Nadh Oxidation/Nad Reduction, Ast/Sgot
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1100
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K093883 | 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- | Seppim S.A.S. | 2010-09-20 |
| K080485 | ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS | Diasys Diagnostics Systems GmbH | 2008-12-04 |
| K071525 | ACTIVATED ASPARTATE AMINOTRANSFERASE | Abbott Laboratories | 2008-03-19 |
| K071580 | AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL | Thermofisher Scientific OY | 2007-10-03 |
| K071211 | COBAS C 111 ANALYZER | Roche Diagnostics | 2007-07-30 |
| K060318 | HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | Horiba Abx | 2006-08-08 |
| K023551 | WIENER LAB GOT (AST) UV AA LIQUIDA | Wiener Laboratories Saic | 2002-12-09 |
| K013698 | AST (SGOT) | Jas Diagnostics, Inc. | 2001-12-21 |
| K013145 | 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. | Wiener Laboratories Saic | 2001-11-27 |
| K010488 | ATAC PAK AST REAGENT KIT | Elan Holdings, Inc. | 2001-04-09 |
| K001679 | VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 | Ortho-Clinical Diagnostics, Inc. | 2000-06-28 |
| K993468 | WAKO L-TYPE GOT TEST | Wako Chemicals USA, Inc. | 1999-12-16 |
| K992136 | BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) | Bayer Corp. | 1999-11-09 |
| K992801 | SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 | Sigma Diagnostics, Inc. | 1999-09-28 |
| K991663 | AST/SGOT | A.P. Total Care, Inc. | 1999-06-30 |
| K990009 | CARESIDE AST | Careside, Inc. | 1999-03-16 |
| K983131 | AST | Abbott Laboratories | 1998-09-28 |
| K981843 | AST | Abbott Laboratories | 1998-06-29 |
| K981650 | AST/SGOT LIQUID REAGENT - KINETIC METHOD | Teco Diagnostics | 1998-06-29 |
| K981225 | ASPARTATE AMINOTRANSFERASE (AST) | Abbott Laboratories | 1998-04-23 |
| K981221 | ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) | Abbott Laboratories | 1998-04-23 |
| K980902 | N-ASSAY L AST/GOT | Crestat Diagnostics, Inc. | 1998-03-26 |
| K980666 | INFINITY AST REAGENT (PROCEDURE NO. 51) | Sigma Diagnostics, Inc. | 1998-03-20 |
| K980030 | AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Trace America, Inc. | 1998-01-30 |
| K974001 | ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30 | Diagnostic Chemicals , Ltd. | 1997-11-13 |
| K971344 | AST OR SGOT | Carolina Liquid Chemistries Corp. | 1997-04-21 |
| K965126 | AST/SGOT | Derma Media Lab., Inc. | 1997-01-17 |
| K961114 | AST INCORPORATING DST | Trace Scientific , Ltd. | 1996-05-23 |
| K954992 | ROCHE COBAS INTEGRA REAGENT CASSETTES | Roche Diagnostic Systems, Inc. | 1996-01-25 |
| K954839 | ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV | Sigma Diagnostics, Inc. | 1996-01-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336130537 | Aspartate Aminotransferase acc. to IFCC II | Roche Diagnostics GmbH | 2024-01-12 |
| 00850053916038 | IDG/Sanzay | IDG/SANZAY Corporation | 2024-01-05 |
| 06971674861874 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861980 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861973 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861966 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861959 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861942 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861935 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861928 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861911 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861904 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861898 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861881 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861867 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861850 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674861997 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674862000 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674862017 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674862024 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 10673486001174 | AST (SGOT) REAGENT SET (UV-KINETIC METHOD) | TECO DIAGNOSTICS | 2023-07-20 |
| 10673486001150 | AST/SGOT LIQUID REAGENT (KINETIC METHOD) | TECO DIAGNOSTICS | 2023-07-20 |
| 10673486001167 | AST (SGOT) KINETIC METHOD TC MATRIX-240/480 | TECO DIAGNOSTICS | 2023-07-20 |
| 00630414008950 | ADVIA Chemistry P5PL_c Reagent | Siemens Healthcare Diagnostics Inc. | 2021-11-04 |
| 00842768000102 | Dimension® Dimension Vista® System Enzyme Diluent | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| EABA40000301 | Piccolo Lipid Panel Plus | ABAXIS, INC. | 2016-09-23 |
| EABA40000281 | Piccolo Comprehensive Metabolic Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000261 | Piccolo Hepatic Function Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000061 | Piccolo General Chemistry 6 | ABAXIS, INC. | 2016-09-23 |
| EABA40000031 | Piccolo Liver Panel Plus | ABAXIS, INC. | 2016-09-23 |