Clearance Summary
BD MAX Check-Points CPO received FDA 510(k) clearance under submission number K190613, sponsored by Check-Points Health B.V.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2019-08-29.
- Submission: K190613
- Applicant / Sponsor: Check-Points Health B.V.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1640
- Decision date: 2019-08-29
Classification & Regulation
This clearance is catalogued under FDA product code POC and 21 CFR 866.1640, within the Microbiology review panel as a Class II device.