Clearance Summary
PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM received FDA 510(k) clearance under submission number K021927, sponsored by Biomet, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2002-07-12.
- Submission: K021927
- Applicant / Sponsor: Biomet, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2050
- Decision date: 2002-07-12
Classification & Regulation
This clearance is catalogued under FDA product code LXG and 21 CFR 862.2050, within the Clinical Chemistry review panel as a Class I device.