K933066 is an FDA 510(k) clearance for the OPUS ESTRADIOL. This device is classified as a Radioimmunoassay, Estradiol (Class I - General Controls, product code CHP).
Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on September 8, 1993, 78 days after receiving the submission on June 22, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1260.
| 510(k) Number | K933066 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 1993 |
| Decision Date | September 08, 1993 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CHP — Radioimmunoassay, Estradiol |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1260 |