Device Listing 1735040343
Listing Summary#
- Listing key
- 1735040343
- Premarket submission
- K193024
- Device
- Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL
- Applicant
- Thermo Fisher Scientific
- Product code
- JWY
- Decision date
- 2020-01-08