K926422 is an FDA 510(k) clearance for the VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY. This device is classified as a Fluid, Diluting, White-cell (Class I - General Controls, product code GGJ).
Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on June 2, 1993, 161 days after receiving the submission on December 23, 1992.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8200.
| 510(k) Number | K926422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1992 |
| Decision Date | June 02, 1993 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GGJ — Fluid, Diluting, White-cell |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.8200 |