PBC Separator with Selux AST System

PBC Separator with Selux AST System is an FDA 510(k)-cleared medical device (K223493) manufactured by Selux 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 February 14, 2024. Regulation: 8.