Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2?g/ml

About This 510(k) Submission

K231988 is an FDA 510(k) clearance for the Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2?g/ml, 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 August 30, 2023, 56 days after receiving the submission on July 5, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.