Clearance Summary
HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) received FDA 510(k) clearance under submission number K191931, sponsored by Hardy Diagnostics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2019-07-31.
- Submission: K191931
- Applicant / Sponsor: Hardy Diagnostics
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1620
- Decision date: 2019-07-31
Classification & Regulation
This clearance is catalogued under FDA product code JTN and 21 CFR 866.1620, within the Microbiology review panel as a Class II device.