Device Listing 1084307362

Listing Summary

Listing key
1084307362
Premarket submission
K242659
Device
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL
Applicant
Thermo Fisher Scientific
Product code
JWY
Decision date
2025-05-22

Related Registrations

Registration keyRegistrationFEICompanyStatusInitial importerExpirationAddress
13646080219143002806332Joel Mathew1N2026-01-0112076 Santa Fe Trail Lenexa KS US 66215