FDA Product Code
FDA Product Code CIT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1100
510(k) Clearances — 139 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K822493 | OPTIMIZED UV-GOT REAGENT SET | Biorent Diagnostic, Inc. | 1982-09-21 | Traditional | PDF ↗ |
| K821208 | SGOT-UV REAGENT SET | Omega Medical Electronics | 1982-07-20 | Traditional | PDF ↗ |
| K821876 | ULTRAZYME PLUS GOT | Harleco Diagnostics | 1982-07-13 | Traditional | PDF ↗ |
| K821433 | BECKMAN LIQUID-STAT AST-UV LIQUID | Beckman Instruments, Inc. | 1982-06-02 | Traditional | PDF ↗ |
| K821467 | ULTRAZYME PLUS GOT, #64953,65033&65034 | Emd Chemicals, Inc. | 1982-06-01 | Traditional | PDF ↗ |
| K820270 | RAICHEM GOT (AST) REAGENT | Reagents Applications, Inc. | 1982-02-18 | Traditional | PDF ↗ |
| K813405 | AST(SGOT) IN VITRO DIAG. REAGENT SET | Pointe Scientific, Inc., | 1981-12-22 | Traditional | PDF ↗ |
| K812592 | ULTRA ZYME PLUS GOT #64953, 65033 & 34 | Harleco | 1981-09-24 | Traditional | PDF ↗ |
| K802447 | GOT ISOENZYME ASSAY EIKEN KIT | Syn-Kit, Inc. | 1981-04-17 | Traditional | PDF ↗ |
| K810727 | AST-UV (PLP-ACTIVATED) DETERMINATION | The Dow Chemical Co. | 1981-03-31 | Traditional | PDF ↗ |
| K810390 | AST (UV) TEST | Boehringer Mannheim Corp. | 1981-02-23 | Traditional | PDF ↗ |
| K803216 | CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT | Union Carbide Corp. | 1981-01-09 | Traditional | PDF ↗ |
| K801856 | DATA-ZYME AST(GOT) PROCEDURE | Data Medical Associates, Inc. | 1980-09-16 | Traditional | PDF ↗ |
| K801118 | COBAS REAGENT FOR AST (SGOT) | Roche Analytical Instruments, Inc. | 1980-06-20 | Traditional | PDF ↗ |
| K800688 | REAGENT FOR DETERM. GLUTAMIC-OXALOACETIC | Diagnostic Solutions, Inc. | 1980-05-28 | Traditional | PDF ↗ |
| K800641 | CENTRIFI CHEM AST/SGOT | Union Carbide Corp. | 1980-04-10 | Traditional | PDF ↗ |
| K800116 | DURAZYME GOT/AST | American Monitor Corp. | 1980-02-13 | Traditional | PDF ↗ |
| K800065 | ASI REAGENT | Gilford Diagnostics | 1980-02-05 | Traditional | PDF ↗ |
| K792208 | DURAZYME GOT/AST | American Monitor Corp. | 1979-11-27 | Traditional | PDF ↗ |
| K791679 | NADH OXIDATION, AST/SGOT | American Monitor Corp. | 1979-09-24 | Traditional | PDF ↗ |
| K791080 | PLUS CHEM S.C.E. REAGENT | Smithkline Diagnostics, Inc. | 1979-07-24 | Traditional | PDF ↗ |
| K791082 | SPIN CHEM REAGENT, DETERMINATION OF AST | Smithkline Diagnostics, Inc. | 1979-07-17 | Traditional | PDF ↗ |
| K790483 | COULTER ACCU-ZYME II GOT REAGENT | Coulter Electronics, Inc. | 1979-05-03 | Traditional | PDF ↗ |
| K790017 | SERUM, GLUTAMIC-OXALOACETIC | Fisher Scientific Co., LLC | 1979-02-26 | Traditional | PDF ↗ |
| K781784 | AST | Gilford Diagnostics | 1979-01-03 | Traditional | PDF ↗ |
| K781725 | REAGENT SET, U.V. ENZMATIC KINETIC, SGOT | Medical Analysis Systems, Inc. | 1978-11-03 | Traditional | PDF ↗ |
| K781020 | (AST) OR (ALT) UV DETERM. PHY. PHOS. | The Dow Chemical Co. | 1978-07-27 | Traditional | PDF ↗ |
| K780634 | SINGLE VIAL 10 SGOT-TRIS | Boehringer Mannheim Corp. | 1978-05-18 | Traditional | PDF ↗ |
| K780463 | AST(GOT) UNI-UV, SGOT | Sclavo, Inc. | 1978-05-12 | Traditional | PDF ↗ |
| K780505 | SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE | Gamma Enterprises, Inc. | 1978-05-03 | Traditional | PDF ↗ |
| K780443 | SGOT/AST REAGENT SYSTEM | American Monitor Corp. | 1978-04-24 | Traditional | PDF ↗ |
| K780103 | ULTRAZYME PLUS GOT | Harleco | 1978-02-13 | Traditional | PDF ↗ |
| K780039 | ASPARTATE TRANSAMINASE | Beckman Instruments, Inc. | 1978-01-31 | Traditional | PDF ↗ |
| K780013 | SERUM GLUTAMIC OXALOACETIC TRANSAMINASE | Macomb Chemical Co. | 1978-01-30 | Traditional | PDF ↗ |
| K772029 | GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT | Harleco | 1977-11-15 | Traditional | PDF ↗ |
| K771153 | DYNA ZYME II GOT 340 | J.T. Baker Chemical Co. | 1977-11-03 | Traditional | PDF ↗ |
| K770318 | REAGENT GOT, ENZYME | Icn Pharmaceuticals, Inc. | 1977-04-05 | Traditional | PDF ↗ |
| K760193 | NDC#12739-0011-1 C-ZYME GOT | Coulter Electronics, Inc. | 1976-08-03 | Traditional | PDF ↗ |
| K760010 | COLORIMETRIC DETERMINATION (SGOT/SGPT) | The Dow Chemical Co. | 1976-07-26 | Traditional | PDF ↗ |
Product code CIT · Class II · Clinical Chemistry. Data: openFDA.