K964841 is an FDA 510(k) clearance for the ELECSYS PROGESTERONE ASSAY. This device is classified as a Radioimmunoassay, Progesterone (Class I - General Controls, product code JLS).
Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on March 24, 1997, 111 days after receiving the submission on December 3, 1996.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1620.
| 510(k) Number | K964841 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1996 |
| Decision Date | March 24, 1997 |
| Days to Decision | 111 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 |