K812004 is an FDA 510(k) clearance for the GASTRIN RIA DIAGNOSTIC KIT. This device is classified as a Radioimmunoassay, Gastrin (Class I - General Controls, product code CGC).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 28, 1981, 14 days after receiving the submission on July 14, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1325.
| 510(k) Number | K812004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1981 |
| Decision Date | July 28, 1981 |
| Days to Decision | 14 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 |