Clearance Summary
REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 received FDA 510(k) clearance under submission number K032139, sponsored by Corgenix, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2004-04-05.
- Submission: K032139
- Applicant / Sponsor: Corgenix, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7290
- Decision date: 2004-04-05
Classification & Regulation
This clearance is catalogued under FDA product code GGP and 21 CFR 864.7290, within the Hematology review panel as a Class II device.