Accelerate Pheno system, Accelerate Phenotest BC Kit

Accelerate Pheno system, Accelerate Phenotest BC Kit is an FDA 510(k)-cleared medical device (DEN160032) manufactured by Accelerate Diagnotics. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 22, 2017. Regulation: 8.