K840088 is an FDA 510(k) clearance for the BIODEX ACT-O-KIT TSH-RIA-. This device is classified as a Radioimmunoassay, Thyroid-stimulating Hormone (Class II - Special Controls, product code JLW).
Submitted by Biodan Medical Systems, Ltd. (Israel, IL). The FDA issued a Cleared decision on May 7, 1984, 118 days after receiving the submission on January 10, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1690.
| 510(k) Number | K840088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 1984 |
| Decision Date | May 07, 1984 |
| Days to Decision | 118 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 |