Clearance Summary
MAMMAPRINT received FDA 510(k) clearance under submission number DEN070009, sponsored by Agendia BV. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2007-02-06.
- Submission: DEN070009
- Applicant / Sponsor: Agendia BV
- Clearance pathway: Post-NSE
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6040
- Decision date: 2007-02-06
Classification & Regulation
This clearance is catalogued under FDA product code NYI and 21 CFR 866.6040, within the Immunology review panel as a Class II device.