K841333 is an FDA 510(k) clearance for the PROGESTERONE DIRECT RIA KIT-RADIOIMM. This device is classified as a Radioimmunoassay, Progesterone (Class I - General Controls, product code JLS).
Submitted by Biotecx Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1984, 30 days after receiving the submission on April 2, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1620.
| 510(k) Number | K841333 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 1984 |
| Decision Date | May 02, 1984 |
| Days to Decision | 30 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 |