Device Listing 1945908889

Listing Summary

Listing key
1945908889
Premarket submission
K243201
Device
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL
Applicant
Thermo Fisher Scientific
Product code
JWY
Decision date
2025-02-10

Related Registrations

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