510(k) K182797

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

K182797 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 Eravacycline in the dilution range of 0.008- 16 µg/mL". The FDA issued a decision of Substantially Equivalent on Nov 30, 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.