Clearance Summary
FEMTEST received FDA 510(k) clearance under submission number K844173, sponsored by Bionexus, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1985-08-14.
- Submission: K844173
- Applicant / Sponsor: Bionexus, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1300
- Decision date: 1985-08-14
Classification & Regulation
This clearance is catalogued under FDA product code HES and 21 CFR 884.1300, within the Obstetrics/Gynecology review panel as a Class II device.