Device Listing 1219142086

Listing Summary#

Listing key
1219142086
Premarket submission
K202612
Device
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)
Applicant
Thermo Fisher Scientific
Product code
JWY
Decision date
2021-07-23