K810722 is an FDA 510(k) clearance for the GASTRIN RADIOIMMUNOASSAY TEST. This device is classified as a Radioimmunoassay, Gastrin (Class I - General Controls, product code CGC).
Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1981, 71 days after receiving the submission on March 17, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1325.
| 510(k) Number | K810722 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 1981 |
| Decision Date | May 27, 1981 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CGC — Radioimmunoassay, Gastrin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1325 |