FDA product code CIS: Hydrazone Colorimetry, Ast/Sgot
CIS is the FDA product code for hydrazone colorimetry, ast/sgot. It is a Class II device, regulated under 21 CFR 862.1100 and reviewed by the Clinical Chemistry panel. FDA has cleared 5 510(k) submissions under CIS, from 5 different applicants. The average 510(k) review took 48 days (median 41).
Classification
| Field | Value |
|---|---|
| Device name | Hydrazone Colorimetry, Ast/Sgot |
| Device class | Class II |
| Regulation | 21 CFR 862.1100 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CIS clearance
Top CIS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cholestech Corp. | 1 | 2003-09-05 |
| Roche Diagnostic Systems, Inc. | 1 | 1990-02-16 |
| Clinical Data, Inc. | 1 | 1985-11-25 |
| Instrumentation Laboratory CO | 1 | 1981-10-26 |
| Volu Sol Medical Industries | 1 | 1979-12-06 |
Most recent CIS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K032027 | Cholestech Corp. | CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) | 2003-09-05 | 66 |
| K896238 | Roche Diagnostic Systems, Inc. | COBAS READY AST REAGENT | 1990-02-16 | 109 |
| K854187 | Clinical Data, Inc. | IN-VITRO TEST DETERMINATION OF SGOT (AST) | 1985-11-25 | 41 |
| K812872 | Instrumentation Laboratory CO | OPTIONAL TOTAL CA-MODULE FOR IL 504/508 | 1981-10-26 | 12 |
| K792410 | Volu Sol Medical Industries | ELVI SGOT & SGPT TRANSAMINASE | 1979-12-06 | 10 |
Recalls for CIS devices
openFDA lists no recalls for product code CIS.
Frequently asked questions
What is FDA product code CIS?
CIS is the FDA product code for hydrazone colorimetry, ast/sgot. It is a Class II device, regulated under 21 CFR 862.1100 and reviewed by the Clinical Chemistry panel.
What device class is CIS?
Class II, regulation 21 CFR 862.1100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CIS?
Across 5 cleared submissions the average was 48 days from receipt to decision (median 41).
Which companies have the most CIS clearances?
Cholestech Corp. (1); Roche Diagnostic Systems, Inc. (1); Clinical Data, Inc. (1); Instrumentation Laboratory CO (1); Volu Sol Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CIS
- Run a recall and safety report across every CIS manufacturer
- Watch product code CIS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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