K800798 is an FDA 510(k) clearance for the HUMAN THYROID STIM. HORMONE/ARIA II. This device is classified as a Radioimmunoassay, Thyroid-stimulating Hormone (Class II - Special Controls, product code JLW).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on April 24, 1980, 15 days after receiving the submission on April 9, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1690.
| 510(k) Number | K800798 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 1980 |
| Decision Date | April 24, 1980 |
| Days to Decision | 15 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 |