Clearance Summary
FILTER, EYRPUR DISPOSABLE LEUKOCITE received FDA 510(k) clearance under submission number K781803, sponsored by Metrix Teknika, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1979-01-17.
- Submission: K781803
- Applicant / Sponsor: Metrix Teknika, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.9245
- Decision date: 1979-01-17
Classification & Regulation
This clearance is catalogued under FDA product code GKT and 21 CFR 864.9245, within the Hematology review panel as a Class II device.