
Gen-Probe Prodesse, Inc.
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PRODESSE PROADENO is an FDA 510(k)-cleared medical device (K102952) manufactured by Gen-Probe Prodesse, 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 December 2, 2010. Regulation: 8.