Accelerate Pheno System, Accelerate PhenoTest BC Kit

Accelerate Pheno System, Accelerate PhenoTest BC Kit is an FDA 510(k)-cleared medical device (K192665) manufactured by Accelerate Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 14, 2020. Regulation: 8.