Clearance Summary
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml received FDA 510(k) clearance under submission number K193538, sponsored by Thermo Fisher Scientific. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2020-03-12.
- Submission: K193538
- Applicant / Sponsor: Thermo Fisher Scientific
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1640
- Decision date: 2020-03-12
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.