Device Listing 1991578472

Listing Summary

Listing key
1991578472
Premarket submission
K192250
Device
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL
Applicant
Thermo Fisher Scientific
Product code
JWY
Decision date
2019-10-16

Related Registrations

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