Clearance Summary
IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) received FDA 510(k) clearance under submission number K071017, sponsored by Siemens Medical Solutions Diagnostics. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2007-05-02.
- Submission: K071017
- Applicant / Sponsor: Siemens Medical Solutions Diagnostics
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5270
- Decision date: 2007-05-02
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.