FDA 510(k) Applications for Medical Device Product Code: NOE (Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2)

FDA 510(k) Applications for Medical Device Product Code "NOE"
(Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K030477	DIADEXUS, INC.	DIADEXUS PLAC TEST	07/18/2003
K050523	DIADEXUS, INC.	DIADEXUS PLAC TEST	06/15/2005
K040101	DIADEXUS, INC.	MODIFICATION TO DIADEXUS PLAC TEST	02/05/2004
K062234	DIADEXUS, INC.	MODIFICATION TO DIADEXUS PLAC TEST	09/11/2006
K141575	DIADEXUS, INC.	PLAC TEST FOR LP-PLA2 ACTIVITY	12/15/2014
K101853	DIADEXUS, INC.	PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115	01/03/2011
K072599	DIADEXUS, INC.	PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109	12/20/2007
K203136	Diazyme Laboratories Inc.	Diazyme PLAC« Test for Lp-PLA2 Activity	08/06/2021