ClearanceBrief
510(k) K252062 ยท JWY Manual Antimicrobial Susceptibility Test Systems

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL

ApplicantThermo Fisher Scientific, Oakwood Village OH, US
DecisionSubstantially Equivalent, Sep 25, 2025
ReceivedJul 1, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K252062

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.