CIT — Nadh Oxidation/Nad Reduction, Ast/Sgot Class II
FDA Device Classification
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 |
| K981843 | abbott laboratories | AST | June 29, 1998 |
| K981650 | teco diagnostics | AST/SGOT LIQUID REAGENT - KINETIC METHOD | June 29, 1998 |
| K981221 | abbott laboratories | ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) | April 23, 1998 |