Clearance Summary
IMMUNOSCAN CCPLUS received FDA 510(k) clearance under submission number K091657, sponsored by Euro-Diagnostica AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2009-11-19.
- Submission: K091657
- Applicant / Sponsor: Euro-Diagnostica AB
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5775
- Decision date: 2009-11-19
Classification & Regulation
This clearance is catalogued under FDA product code NHX and 21 CFR 866.5775, within the Immunology review panel as a Class II device.