510(k) K223844

Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae) by Thermo Fisher Scientific — Product Code JWY

K223844 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific for the device "Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)". The FDA issued a decision of Substantially Equivalent on Mar 21, 2023. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Thermo Fisher Scientific has 64 other 510(k) clearances on record.