Clearance Summary
K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE received FDA 510(k) clearance under submission number K002558, sponsored by Kamiya Biomedical Co.. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2000-10-25.
- Submission: K002558
- Applicant / Sponsor: Kamiya Biomedical Co.
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5270
- Decision date: 2000-10-25
Classification & Regulation
This clearance is catalogued under FDA product code DCK and 21 CFR 866.5270, within the Immunology review panel as a Class II device.