Clearance Summary
FACT PLUS ONE-STEP PREGNANCY TEST KIT received FDA 510(k) clearance under submission number K042280, 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 2004-09-10.
- Submission: K042280
- Applicant / Sponsor: Unipath , Ltd.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 2004-09-10
Classification & Regulation
This clearance is catalogued under FDA product code LCX and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.