K874866 is an FDA 510(k) clearance for the T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE. This device is classified as a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II - Special Controls, product code KLI).
Submitted by Serono Diagnostics, Inc. (Norwell, US). The FDA issued a Cleared decision on February 11, 1988, 76 days after receiving the submission on November 27, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1700.
| 510(k) Number | K874866 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 1987 |
| Decision Date | February 11, 1988 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1700 |