Clearance Summary
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 received FDA 510(k) clearance under submission number K043007, sponsored by Hyphen Biomed. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2005-11-07.
- Submission: K043007
- Applicant / Sponsor: Hyphen Biomed
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7060
- Decision date: 2005-11-07
Classification & Regulation
This clearance is catalogued under FDA product code JBQ and 21 CFR 864.7060, within the Hematology review panel as a Class II device.