K871211 is an FDA 510(k) clearance for the PROGESTERONE CLASP RADIOIMMUNOASSAY KIT. This device is classified as a Radioimmunoassay, Progesterone (Class I — General Controls, product code JLS).
Submitted by Biotecx Laboratories, Inc. (Friendswood, US). The FDA issued a Cleared decision on April 13, 1987, 18 days after receiving the submission on March 26, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1620.
| 510(k) Number | K871211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 1987 |
| Decision Date | April 13, 1987 |
| Days to Decision | 18 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 |