Device Listing 2031854099

Listing Summary

Listing key
2031854099
Premarket submission
K183324
Device
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL
Applicant
Thermo Fisher Scientific
Product code
JWY
Decision date
2019-02-15

Related Registrations

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