Clearance Summary
AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY received FDA 510(k) clearance under submission number K892645, sponsored by Amicon, 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 1989-06-13.
- Submission: K892645
- Applicant / Sponsor: Amicon, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2240
- Decision date: 1989-06-13
Classification & Regulation
This clearance is catalogued under FDA product code KJF and 21 CFR 864.2240, within the Hematology review panel as a Class I device.