K812872 is an FDA 510(k) clearance for the OPTIONAL TOTAL CA-MODULE FOR IL 504/508. This device is classified as a Hydrazone Colorimetry, Ast/sgot (Class II - Special Controls, product code CIS).
Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on October 26, 1981, 12 days after receiving the submission on October 14, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1100.
| 510(k) Number | K812872 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1981 |
| Decision Date | October 26, 1981 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CIS — Hydrazone Colorimetry, Ast/sgot |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1100 |