Diadexus, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K141575PLAC TEST FOR LP-PLA2 ACTIVITYDecember 15, 2014
K101853PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115January 3, 2011
K072599PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109December 20, 2007
K062234MODIFICATION TO DIADEXUS PLAC TESTSeptember 11, 2006
K050523DIADEXUS PLAC TESTJune 15, 2005
K040101MODIFICATION TO DIADEXUS PLAC TESTFebruary 5, 2004
K030477DIADEXUS PLAC TESTJuly 18, 2003