ClearanceBrief
510(k) K242653 ยท JWY Manual Antimicrobial Susceptibility Test Systems

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL

ApplicantThermo Fisher Scientific, Oakwood Village OH, US
DecisionSubstantially Equivalent, Dec 5, 2024
ReceivedSep 4, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K242653

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.