K042281 is an FDA 510(k) clearance for the MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY. This device is classified as a Radioimmunoassay, Thyroid-stimulating Hormone (Class II - Special Controls, product code JLW).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on September 16, 2004, 23 days after receiving the submission on August 24, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1690.
| 510(k) Number | K042281 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2004 |
| Decision Date | September 16, 2004 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JLW — Radioimmunoassay, Thyroid-stimulating Hormone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1690 |