Clearance Summary
GENESISCS COMPONENT CONCENTRATING SYSTEM received FDA 510(k) clearance under submission number K070666, sponsored by Perfusion Partners & Assoc., 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 2007-06-20.
- Submission: K070666
- Applicant / Sponsor: Perfusion Partners & Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2050
- Decision date: 2007-06-20
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.