Clearance Summary
VACU-PRO received FDA 510(k) clearance under submission number K922445, sponsored by Concord/Portex. 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 1992-08-12.
- Submission: K922445
- Applicant / Sponsor: Concord/Portex
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 1992-08-12
Classification & Regulation
This clearance is catalogued under FDA product code JKA and 21 CFR 862.1675, within the Clinical Chemistry review panel as a Class II device.