K812227 is an FDA 510(k) clearance for the GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY. This device is classified as a Radioimmunoassay, Immunoreactive Insulin (Class I - General Controls, product code CFP).
Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 24, 1981, 45 days after receiving the submission on August 10, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1405.
| 510(k) Number | K812227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1981 |
| Decision Date | September 24, 1981 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CFP — Radioimmunoassay, Immunoreactive Insulin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1405 |