K792167 is an FDA 510(k) clearance for the 125 I FOLATE SOLID PHASE RADIOASSAY. This device is classified as a Acid, Folic, Radioimmunoassay (Class II - Special Controls, product code CGN).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 13, 1979, 18 days after receiving the submission on October 26, 1979.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1295.
| 510(k) Number | K792167 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 1979 |
| Decision Date | November 13, 1979 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CGN — Acid, Folic, Radioimmunoassay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1295 |