Clearance Summary
ABX MICROS CRP 200, OPTION IM received FDA 510(k) clearance under submission number K053308, sponsored by Horiba Abx. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2005-12-29.
- Submission: K053308
- Applicant / Sponsor: Horiba Abx
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 2005-12-29
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.