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