K781546 is an FDA 510(k) clearance for the DIRECT ESTRIOL RIA KIT. This device is classified as a Radioimmunoassay, Estriol (Class I - General Controls, product code CGI).
Submitted by Immunalysis Corporation (Mchenry, US). The FDA issued a Cleared decision on December 4, 1978, 82 days after receiving the submission on September 13, 1978.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1265.
| 510(k) Number | K781546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 1978 |
| Decision Date | December 04, 1978 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CGI — Radioimmunoassay, Estriol |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1265 |