K880388 is an FDA 510(k) clearance for the T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE. This device is classified as a Radioimmunoassay, Total Triiodothyronine (Class II - Special Controls, product code CDP).
Submitted by Serono Diagnostics, Inc. (Norwell, US). The FDA issued a Cleared decision on March 3, 1988, 35 days after receiving the submission on January 28, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1710.
| 510(k) Number | K880388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 1988 |
| Decision Date | March 03, 1988 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDP — Radioimmunoassay, Total Triiodothyronine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1710 |