
Trek Diagnostic Systems, Inc.
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SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS is an FDA 510(k)-cleared medical device (K081063) 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 March 5, 2009. Regulation: 8.