MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST

MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST is an FDA 510(k)-cleared medical device (K991810) manufactured by Trek Diagnostic Systems, 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 October 8, 2001. Regulation: 8.