K844767 is an FDA 510(k) clearance for the RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO. This device is classified as a Radioimmunoassay, Estriol (Class I - General Controls, product code CGI).
Submitted by Biotecx Laboratories, Inc. (Friendswood, US). The FDA issued a Cleared decision on February 1, 1985, 56 days after receiving the submission on December 7, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1265.
| 510(k) Number | K844767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 1984 |
| Decision Date | February 01, 1985 |
| Days to Decision | 56 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 |