The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml

The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml is an FDA 510(k)-cleared medical device (K221899) manufactured by Thermo Fisher Scientific. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 19, 2023. Regulation: 8.