Clearance Summary
CardioPhase® hsCRP received FDA 510(k) clearance under submission number K212559, sponsored by Siemens Healthcare Diagnostics Products GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2022-12-16.
- Submission: K212559
- Applicant / Sponsor: Siemens Healthcare Diagnostics Products GmbH
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5270
- Decision date: 2022-12-16
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.