FDA Product Code
FDA Product Code CIS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1100
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K032027 | CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) | Cholestech Corp. | 2003-09-05 | Traditional | PDF ↗ |
| K896238 | COBAS READY AST REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K854187 | IN-VITRO TEST DETERMINATION OF SGOT (AST) | Clinical Data, Inc. | 1985-11-25 | Traditional | PDF ↗ |
| K812872 | OPTIONAL TOTAL CA-MODULE FOR IL 504/508 | Instrumentation Laboratory CO | 1981-10-26 | Traditional | PDF ↗ |
| K792410 | ELVI SGOT & SGPT TRANSAMINASE | Volu Sol Medical Industries | 1979-12-06 | Traditional | PDF ↗ |
Product code CIS · Class II · Clinical Chemistry. Data: openFDA.