510(k) K192729

Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml by Thermo Fisher Scientific — Product Code JWY

K192729 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 Lefamulin in the dilution range of 0.008-16ug/ml". The FDA issued a decision of Substantially Equivalent on Nov 6, 2019. 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.