Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL

About This 510(k) Submission

K231994 is an FDA 510(k) clearance for the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 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 August 25, 2023, 51 days after receiving the submission on July 5, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.