Clearance Summary
FilmArray BCID2 Control Panel M416 received FDA 510(k) clearance under submission number K200010, sponsored by Maine Molecular Quality Controls, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2020-04-02.
- Submission: K200010
- Applicant / Sponsor: Maine Molecular Quality Controls, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3920
- Decision date: 2020-04-02
Classification & Regulation
This clearance is catalogued under FDA product code PMN and 21 CFR 866.3920, within the Microbiology review panel as a Class II device.