Clearance Summary
IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST received FDA 510(k) clearance under submission number K132978, sponsored by Sequenom, 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 2014-06-13.
- Submission: K132978
- Applicant / Sponsor: Sequenom, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7280
- Decision date: 2014-06-13
Classification & Regulation
This clearance is catalogued under FDA product code PHJ and 21 CFR 864.7280, within the Hematology review panel as a Class II device.