K234091 is an FDA 510(k) clearance for the Maverick Diagnostic System TC1000. This device is classified as a Radioimmunoassay, Thyroid-stimulating Hormone (Class II - Special Controls, product code JLW).
Submitted by Genalyte, Inc. (San Diego, US). The FDA issued a Cleared decision on July 22, 2024, 209 days after receiving the submission on December 26, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1690.
| 510(k) Number | K234091 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2023 |
| Decision Date | July 22, 2024 |
| Days to Decision | 209 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 |