Clearance Summary
IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP received FDA 510(k) clearance under submission number K063057, sponsored by Diagnostic Products Corporation. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2006-12-22.
- Submission: K063057
- Applicant / Sponsor: Diagnostic Products Corporation
- Clearance pathway: Abbreviated
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5270
- Decision date: 2006-12-22
Classification & Regulation
This clearance is catalogued under FDA product code NQD and 21 CFR 866.5270, within the Immunology review panel as a Class II device.