Clearance Summary
SMARTPREP2 CENTRIFUGE SYSTEM received FDA 510(k) clearance under submission number K052925, sponsored by Harvest Technologies, Corp.. 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 2006-01-04.
- Submission: K052925
- Applicant / Sponsor: Harvest Technologies, Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2050
- Decision date: 2006-01-04
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.