510(k) K203741

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml by Thermo Fisher Scientific — Product Code JWY

K203741 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific for the device "Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml". The FDA issued a decision of Substantially Equivalent on Dec 20, 2021. 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.