Clearance Summary
PEFAKIT APC-R FACTOR V LEIDEN received FDA 510(k) clearance under submission number K042762, sponsored by Pentapharm , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2004-12-22.
- Submission: K042762
- Applicant / Sponsor: Pentapharm , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7925
- Decision date: 2004-12-22
Classification & Regulation
This clearance is catalogued under FDA product code GGW and 21 CFR 864.7925, within the Hematology review panel as a Class II device.