K895396 is an FDA 510(k) clearance for the CYBERFLUOR FIAGEN TSH. This device is classified as a Radioimmunoassay, Thyroid-stimulating Hormone (Class II - Special Controls, product code JLW).
Submitted by Cyberfluor, Inc. (Ontario M5t 1x4, CA). The FDA issued a Cleared decision on October 31, 1989, 60 days after receiving the submission on September 1, 1989.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1690.
| 510(k) Number | K895396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1989 |
| Decision Date | October 31, 1989 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | JLW — Radioimmunoassay, Thyroid-stimulating Hormone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1690 |