510(k) K250575

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 by Thermo Fisher Scientific — Product Code JWY

K250575 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific for the device "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". The FDA issued a decision of Substantially Equivalent on September 5, 2025. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Thermo Fisher Scientific has at least 10 other 510(k) clearances on record.