K965084 is an FDA 510(k) clearance for the VIDAS PROESTERONE (PRG) (30 409). This device is classified as a Radioimmunoassay, Progesterone (Class I - General Controls, product code JLS).
Submitted by bioMerieux, Inc. (Rockland, US). The FDA issued a Cleared decision on January 9, 1997, 21 days after receiving the submission on December 19, 1996.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1620.
| 510(k) Number | K965084 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 1996 |
| Decision Date | January 09, 1997 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JLS — Radioimmunoassay, Progesterone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1620 |