Clearance Summary
ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) received FDA 510(k) clearance under submission number K890997, sponsored by Atlantic Wholesale, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1989-03-28.
- Submission: K890997
- Applicant / Sponsor: Atlantic Wholesale, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2230
- Decision date: 1989-03-28
Classification & Regulation
This clearance is catalogued under FDA product code KEA and 21 CFR 862.2230, within the Clinical Chemistry review panel as a Class I device.