Clearance Summary
CHEMPAQ XBC ANALYZER received FDA 510(k) clearance under submission number K090013, sponsored by Chempaq A/S. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2009-04-21.
- Submission: K090013
- Applicant / Sponsor: Chempaq A/S
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 2009-04-21
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.