Clearance Summary
CHEMPAQ XBC ANALYZER received FDA 510(k) clearance under submission number K050758, sponsored by Chempaq A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2005-12-22.
- Submission: K050758
- Applicant / Sponsor: Chempaq A/S
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 2005-12-22
Classification & Regulation
This clearance is catalogued under FDA product code GKZ and 21 CFR 864.5220, within the Hematology review panel as a Class II device.