FDA 510(k) Applications Submitted by DIADEXUS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K050523 |
03/02/2005 |
DIADEXUS PLAC TEST |
DIADEXUS, INC. |
| K141575 |
06/12/2014 |
PLAC TEST FOR LP-PLA2 ACTIVITY |
DIADEXUS, INC. |
| K101853 |
07/01/2010 |
PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 |
DIADEXUS, INC. |
| K072599 |
09/14/2007 |
PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 |
DIADEXUS, INC. |
| K040101 |
01/20/2004 |
MODIFICATION TO DIADEXUS PLAC TEST |
DIADEXUS, INC. |
| K030477 |
02/13/2003 |
DIADEXUS PLAC TEST |
DIADEXUS, INC. |
| K062234 |
08/02/2006 |
MODIFICATION TO DIADEXUS PLAC TEST |
DIADEXUS, INC. |
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