SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES is an FDA 510(k)-cleared medical device (K092445) manufactured by Trek Diagnostic Systems, Ltd.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 2009. Regulation: 8.