510(k) K230935

Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) by Thermo Fisher Scientific — Product Code JWY

K230935 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 Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)". The FDA issued a decision of Substantially Equivalent on June 30, 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.