Clearance Summary
HAEMONETICS 600 ML. COMPONENT BAG received FDA 510(k) clearance under submission number K810711, sponsored by Haemonetics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1981-05-08.
- Submission: K810711
- Applicant / Sponsor: Haemonetics Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.9100
- Decision date: 1981-05-08
Classification & Regulation
This clearance is catalogued under FDA product code KSR and 21 CFR 864.9100, within the Hematology review panel as a Class II device.