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)

About This 510(k) Submission

K223844 is an FDA 510(k) clearance for the 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), a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Thermo Fisher Scientific (Oakwood Village, US). The FDA issued a Cleared decision on March 21, 2023, 89 days after receiving the submission on December 22, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.