K840886 is an FDA 510(k) clearance for the HYDROXYPROGESTERONE BY RIA 17A. This device is classified as a Radioimmunoassay, Progesterone (Class I - General Controls, product code JLS).
Submitted by Radioassay Systems Laboratories, Inc. (Anaheim, US). The FDA issued a Cleared decision on April 18, 1984, 51 days after receiving the submission on February 27, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1620.
| 510(k) Number | K840886 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1984 |
| Decision Date | April 18, 1984 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JLS — Radioimmunoassay, Progesterone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1620 |