Device Listing 1094597448

Listing Summary

Listing key
1094597448
Premarket submission
K172274
Device
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL
Applicant
Thermo Fisher Scientific
Product code
JWY
Decision date
2017-08-30

Related Registrations

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