Clearance Summary
PRO QR ADVANCED FORMULA POWDER received FDA 510(k) clearance under submission number K080210, sponsored by Biolife, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2009-02-10.
- Submission: K080210
- Applicant / Sponsor: Biolife, LLC
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2009-02-10
Classification & Regulation
This clearance is catalogued under FDA product code QSY , within the Unknown review panel as a device.