K955025 is an FDA 510(k) clearance for the AXSYM PROGESTERONE. This device is classified as a Radioimmunoassay, Progesterone (Class I - General Controls, product code JLS).
Submitted by Abbott Laboratories (Buffalo, US). The FDA issued a Cleared decision on March 7, 1996, 126 days after receiving the submission on November 2, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1620.
| 510(k) Number | K955025 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1995 |
| Decision Date | March 07, 1996 |
| Days to Decision | 126 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 |