510(k) K193024

Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL by Thermo Fisher Scientific — Product Code JWY

K193024 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 Lefamulin in the dilution range of 0.008-16ug/mL". The FDA issued a decision of Substantially Equivalent on Jan 8, 2020. 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.