Clearance Summary
MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR received FDA 510(k) clearance under submission number K990223, sponsored by Unipath , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1999-02-24.
- Submission: K990223
- Applicant / Sponsor: Unipath , Ltd.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1485
- Decision date: 1999-02-24
Classification & Regulation
This clearance is catalogued under FDA product code NGE and 21 CFR 862.1485, within the Clinical Chemistry review panel as a Class I device.