510(k) K232310

Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml by Thermo Fisher Scientific — Product Code JWY

K232310 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific for the device "Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml". The FDA issued a decision of Substantially Equivalent on October 31, 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 at least 10 other 510(k) clearances on record.