K903359 is an FDA 510(k) clearance for the MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT. This device is classified as a Radioimmunoassay, Estriol (Class I - General Controls, product code CGI).
Submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on August 22, 1990, 28 days after receiving the submission on July 25, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1265.
| 510(k) Number | K903359 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1990 |
| Decision Date | August 22, 1990 |
| Days to Decision | 28 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 |