
Diadexus, Inc.
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PLAC TEST FOR LP-PLA2 ACTIVITY is an FDA 510(k)-cleared medical device (K141575) 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 December 14, 2014. Regulation: 8.