K844511 is an FDA 510(k) clearance for the TDX TOTAL ESTRIOL. This device is classified as a Radioimmunoassay, Estriol (Class I - General Controls, product code CGI).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 18, 1985, 59 days after receiving the submission on November 20, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1265.
| 510(k) Number | K844511 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 1984 |
| Decision Date | January 18, 1985 |
| Days to Decision | 59 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 |