Clearance Summary
CLEARPLAN EASY OVULATION TEST received FDA 510(k) clearance under submission number K981271, sponsored by Unipath , Ltd.. 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 1998-06-25.
- Submission: K981271
- Applicant / Sponsor: Unipath , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1485
- Decision date: 1998-06-25
Classification & Regulation
This clearance is catalogued under FDA product code CEP and 21 CFR 862.1485, within the Clinical Chemistry review panel as a Class I device.