K001455 is an FDA 510(k) clearance for the ACCUWELL TSH, MODEL KAW-TSH-960. This device is classified as a Radioimmunoassay, Thyroid-stimulating Hormone (Class II - Special Controls, product code JLW).
Submitted by Neometrics, Inc. (E. Northport, US). The FDA issued a Cleared decision on November 2, 2000, 177 days after receiving the submission on May 9, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1690.
| 510(k) Number | K001455 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2000 |
| Decision Date | November 02, 2000 |
| Days to Decision | 177 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 |