K864966 is an FDA 510(k) clearance for the ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE. This device is classified as a Radioimmunoassay, Estrone (Class I - General Controls, product code CGF).
Submitted by Diagnostics Biochem Canada, Inc. (London, Ontario, CA). The FDA issued a Cleared decision on January 9, 1987, 18 days after receiving the submission on December 22, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1280.
| 510(k) Number | K864966 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1986 |
| Decision Date | January 09, 1987 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CGF — Radioimmunoassay, Estrone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1280 |