Clearance Summary
BACT/ALERT MP Reagent System received FDA 510(k) clearance under submission number K190405, sponsored by bioMerieux, 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 2019-05-15.
- Submission: K190405
- Applicant / Sponsor: bioMerieux, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class I
- Regulation citation: 21 CFR 866.2560
- Decision date: 2019-05-15
Classification & Regulation
This clearance is catalogued under FDA product code MDB and 21 CFR 866.2560, within the Microbiology review panel as a Class I device.