SENSITITRE YEASTONE SUSCEPTIBILITY PLATES

SENSITITRE YEASTONE SUSCEPTIBILITY PLATES is an FDA 510(k)-cleared medical device (K133038) manufactured by Trek Diagnostic Systems. 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 30, 2014. Regulation: 8.