Clearance Summary
FERTELL MALE FERTILITY TEST received FDA 510(k) clearance under submission number K041039, sponsored by Genosis , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2004-07-20.
- Submission: K041039
- Applicant / Sponsor: Genosis , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 2004-07-20
Classification & Regulation
This clearance is catalogued under FDA product code POV and 21 CFR 864.5220, within the Hematology review panel as a Class II device.