Clearance Summary
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) received FDA 510(k) clearance under submission number K192355, sponsored by Beckman Coulter, 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 2019-11-14.
- Submission: K192355
- Applicant / Sponsor: Beckman Coulter, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1640
- Decision date: 2019-11-14
Classification & Regulation
This clearance is catalogued under FDA product code JWY and 21 CFR 866.1640, within the Microbiology review panel as a Class II device.