Clearance Summary
FACT* HOME PREGNANCY TEST received FDA 510(k) clearance under submission number K810581, sponsored by Ortho Pharmaceutical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1981-03-17.
- Submission: K810581
- Applicant / Sponsor: Ortho Pharmaceutical Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 1981-03-17
Classification & Regulation
This clearance is catalogued under FDA product code JHJ and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.