The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL

About This 510(k) Submission

K250990 is an FDA 510(k) clearance for the The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Thermo Fisher Scientific (Oakwood Village, US). The FDA issued a Cleared decision on June 30, 2025, 91 days after receiving the submission on March 31, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.