K250575
- 510(k) number
- K250575
- Device name
- The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL
- Applicant
- Thermo Fisher Scientific OH · US
- Product code
- JWY — Manual Antimicrobial Susceptibility Test Systems
- Decision date
- 2025-09-05
- Date received
- 2025-02-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K250575
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.