510(k) K181946

Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL by Thermo Fisher Scientific — Product Code JWY

K181946 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific for the device "Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL". The FDA issued a decision of Substantially Equivalent on Aug 8, 2018. 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.