K982954 is an FDA 510(k) clearance for the FREE T4 MICROWELL EIA, MODEL #7019. This device is classified as a Radioimmunoassay, Free Thyroxine (Class II - Special Controls, product code CEC).
Submitted by Biomerica, Inc. (Newport Beach, US). The FDA issued a Cleared decision on September 24, 1998, 31 days after receiving the submission on August 24, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1695.
| 510(k) Number | K982954 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 1998 |
| Decision Date | September 24, 1998 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CEC - Radioimmunoassay, Free Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1695 |