Clearance Summary
BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR received FDA 510(k) clearance under submission number K043451, sponsored by Hyphen Biomed. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2005-03-17.
- Submission: K043451
- Applicant / Sponsor: Hyphen Biomed
- Clearance pathway: Abbreviated
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 2005-03-17
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.