K791747 is an FDA 510(k) clearance for the HTSH NEONATE RIA DIAGNOSTIC KIT. This device is classified as a Radioimmunoassay, Thyroid-stimulating Hormone (Class II - Special Controls, product code JLW).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 13, 1979, 64 days after receiving the submission on September 10, 1979.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1690.
| 510(k) Number | K791747 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 1979 |
| Decision Date | November 13, 1979 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JLW — Radioimmunoassay, Thyroid-stimulating Hormone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1690 |