K962216 is an FDA 510(k) clearance for the TSH (MICROWELL) ELISA. This device is classified as a Radioimmunoassay, Thyroid-stimulating Hormone (Class II - Special Controls, product code JLW).
Submitted by Biomerica, Inc. (Newport Beach, US). The FDA issued a Cleared decision on September 19, 1996, 101 days after receiving the submission on June 10, 1996.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1690.
| 510(k) Number | K962216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 1996 |
| Decision Date | September 19, 1996 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JLW - Radioimmunoassay, Thyroid-stimulating Hormone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1690 |