K920230 is an FDA 510(k) clearance for the AFFINITY PRG. This device is classified as a Radioimmunoassay, Progesterone (Class I - General Controls, product code JLS).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Cockeysville, US). The FDA issued a Cleared decision on February 18, 1992, 32 days after receiving the submission on January 17, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1620.
| 510(k) Number | K920230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 1992 |
| Decision Date | February 18, 1992 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JLS — Radioimmunoassay, Progesterone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1620 |