Clearance Summary
PEFAKIT APC-R FACTOR V LEIDEN CONTROLS received FDA 510(k) clearance under submission number K042760, sponsored by Pentapharm , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2004-12-22.
- Submission: K042760
- Applicant / Sponsor: Pentapharm , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 2004-12-22
Classification & Regulation
This clearance is catalogued under FDA product code GGN and 21 CFR 864.5425, within the Hematology review panel as a Class II device.