Clearance Summary
MMPC-4127F1 received FDA 510(k) clearance under submission number K172922, sponsored by Barco N.V.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2017-12-21.
- Submission: K172922
- Applicant / Sponsor: Barco N.V.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class II
- Regulation citation: 21 CFR 864.3700
- Decision date: 2017-12-21
Classification & Regulation
This clearance is catalogued under FDA product code PZZ and 21 CFR 864.3700, within the Pathology review panel as a Class II device.