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Diadexus, Inc.
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PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 is an FDA 510(k)-cleared medical device (K101853) manufactured by Diadexus, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 2, 2011. Regulation: 8.