510(k) K243169

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL by Thermo Fisher Scientific — Product Code JWY

K243169 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific for the device "The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL". The FDA issued a decision of Substantially Equivalent on December 19, 2024. 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.