K780219 is an FDA 510(k) clearance for the ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY. This device is classified as a Radioimmunoassay, Total Thyroxine (Class II - Special Controls, product code CDX).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on March 3, 1978, 21 days after receiving the submission on February 10, 1978.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1700.
| 510(k) Number | K780219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 1978 |
| Decision Date | March 03, 1978 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDX — Radioimmunoassay, Total Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1700 |