Clearance Summary
HAEMOFUGE A. BIOFUGE A. & B received FDA 510(k) clearance under submission number K840767, sponsored by Heraeus-Christ GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1984-04-17.
- Submission: K840767
- Applicant / Sponsor: Heraeus-Christ GmbH
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6400
- Decision date: 1984-04-17
Classification & Regulation
This clearance is catalogued under FDA product code JPI and 21 CFR 864.6400, within the Hematology review panel as a Class II device.