CIS — Hydrazone Colorimetry, Ast/Sgot Class II
FDA Device Classification
Classification Details
- Product Code
- CIS
- 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 |
|---|
| K032027 | cholestech | CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) | September 5, 2003 |
| K896238 | roche diagnostic systems | COBAS READY AST REAGENT | February 16, 1990 |
| K854187 | clinical data | IN-VITRO TEST DETERMINATION OF SGOT (AST) | November 25, 1985 |
| K812872 | instrumentation laboratory | OPTIONAL TOTAL CA-MODULE FOR IL 504/508 | October 26, 1981 |
| K792410 | volu sol medical industries | ELVI SGOT & SGPT TRANSAMINASE | December 6, 1979 |