Panels › Clinical Chemistry › Product code CIS · Class 2
Hydrazone Colorimetry, Ast/Sgot
Regulation 862.1100
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in CIS
| Company | 510(k)s | Recalls |
|---|---|---|
| Cholestech Corp. | 1 | 0 |
| Clinical Data, Inc. | 1 | 0 |
| Instrumentation Laboratory CO | 1 | 0 |
| Roche Diagnostic Systems, Inc. | 1 | 0 |
| Volu Sol Medical Industries | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 5, 2003 | K032027 | CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) Cholestech Corp. | CIS |
| Feb 16, 1990 | K896238 | COBAS READY AST REAGENT Roche Diagnostic Systems, Inc. | CIS |
| Nov 25, 1985 | K854187 | IN-VITRO TEST DETERMINATION OF SGOT (AST) Clinical Data, Inc. | CIS |
| Oct 26, 1981 | K812872 | OPTIONAL TOTAL CA-MODULE FOR IL 504/508 Instrumentation Laboratory CO | CIS |
| Dec 6, 1979 | K792410 | ELVI SGOT & SGPT TRANSAMINASE Volu Sol Medical Industries | CIS |
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