CIT — Nadh Oxidation/Nad Reduction, Ast/Sgot Class II
FDA product code CIT covers "Nadh Oxidation/Nad Reduction, Ast/Sgot", a Class II medical device regulated under 21 CFR 862.1100. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CIT
- Device Class
- Class II
- Regulation Number
- 862.1100
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K093883 | seppim | AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250 | September 20, 2010 |
| K080485 | diasys diagnostics systems | ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS | December 4, 2008 |
| K071525 | abbott laboratories | ACTIVATED ASPARTATE AMINOTRANSFERASE | March 19, 2008 |
| K071580 | thermofisher scientific | AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL | October 3, 2007 |
| K071211 | roche diagnostics | COBAS C 111 ANALYZER | July 30, 2007 |
| K060318 | horiba abx | HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | August 8, 2006 |
| K023551 | wiener laboratories saic | WIENER LAB GOT (AST) UV AA LIQUIDA | December 9, 2002 |
| K013698 | jas diagnostics | AST (SGOT) | December 21, 2001 |
| K013145 | wiener laboratories saic | WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML | November 27, 2001 |
| K010488 | elan holdings | ATAC PAK AST REAGENT KIT | April 9, 2001 |
| K001679 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 | June 28, 2000 |
| K993468 | wako chemicals usa | WAKO L-TYPE GOT TEST | December 16, 1999 |
| K992136 | bayer | BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) | November 9, 1999 |
| K992801 | sigma diagnostics | SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINI | September 28, 1999 |
| K991663 | a.p. total care | AST/SGOT | June 30, 1999 |
| K990009 | careside | CARESIDE AST | March 16, 1999 |
| K983131 | abbott laboratories | AST | September 28, 1998 |
| K981650 | teco diagnostics | AST/SGOT LIQUID REAGENT - KINETIC METHOD | June 29, 1998 |
| K981843 | abbott laboratories | AST | June 29, 1998 |
| K981221 | abbott laboratories | ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) | April 23, 1998 |