Clearance Summary
PLASMA EXTRACTION SYSTEM received FDA 510(k) clearance under submission number K850391, sponsored by Hans J. Brouwers & Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1985-05-10.
- Submission: K850391
- Applicant / Sponsor: Hans J. Brouwers & Assoc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6400
- Decision date: 1985-05-10
Classification & Regulation
This clearance is catalogued under FDA product code JPI and 21 CFR 864.6400, within the Hematology review panel as a Class II device.