Clearance Summary
VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY received FDA 510(k) clearance under submission number K926422, sponsored by Syva Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1993-06-02.
- Submission: K926422
- Applicant / Sponsor: Syva Co.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8200
- Decision date: 1993-06-02
Classification & Regulation
This clearance is catalogued under FDA product code GGJ and 21 CFR 864.8200, within the Hematology review panel as a Class I device.