K884100 is an FDA 510(k) clearance for the AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144. This device is classified as a Radioimmunoassay, Progesterone (Class I - General Controls, product code JLS).
Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on November 10, 1988, 43 days after receiving the submission on September 28, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1620.
| 510(k) Number | K884100 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 1988 |
| Decision Date | November 10, 1988 |
| Days to Decision | 43 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 |