The following data is part of a premarket notification filed by Syva Co. with the FDA for Vista(r) Human Follicle-stim Hormone(hfsh) Assay.
| Device ID | K926422 |
| 510k Number | K926422 |
| Device Name: | VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY |
| Classification | Fluid, Diluting, White-cell |
| Applicant | SYVA CO. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Contact | Paul L Rogers |
| Correspondent | Paul L Rogers SYVA CO. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Product Code | GGJ |
| CFR Regulation Number | 864.8200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-23 |
| Decision Date | 1993-06-02 |