K801735 is an FDA 510(k) clearance for the ARIA II 125- I-ESTRIOL SYSTEM. This device is classified as a Radioimmunoassay, Estriol (Class I - General Controls, product code CGI).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on September 16, 1980, 53 days after receiving the submission on July 25, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1265.
| 510(k) Number | K801735 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1980 |
| Decision Date | September 16, 1980 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CGI — Radioimmunoassay, Estriol |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1265 |