K770732 is an FDA 510(k) clearance for the REAGENT SYSTEM, PROGESTERONE, ARIA. This device is classified as a Radioimmunoassay, Progesterone (Class I - General Controls, product code JLS).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on June 22, 1977, 63 days after receiving the submission on April 20, 1977.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1620.
| 510(k) Number | K770732 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 1977 |
| Decision Date | June 22, 1977 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JLS — Radioimmunoassay, Progesterone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1620 |