Clearance Summary
3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM received FDA 510(k) clearance under submission number K994148, sponsored by Implant Innovations, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2000-02-01.
- Submission: K994148
- Applicant / Sponsor: Implant Innovations, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2050
- Decision date: 2000-02-01
Classification & Regulation
This clearance is catalogued under FDA product code JQC and 21 CFR 862.2050, within the Clinical Chemistry review panel as a Class I device.