K910249 is an FDA 510(k) clearance for the STRATUS ESTRADIOL FLUOREMETRIC ENZYME. This device is classified as a Radioimmunoassay, Estradiol (Class I - General Controls, product code CHP).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on February 13, 1991, 22 days after receiving the submission on January 22, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1260.
| 510(k) Number | K910249 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 1991 |
| Decision Date | February 13, 1991 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CHP — Radioimmunoassay, Estradiol |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1260 |