FDA 510(k) Application Details - K101853

Device Classification Name	Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2   More FDA Info for this Device
510(K) Number	K101853
Device Name	Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
Applicant	DIADEXUS, INC. 343 OYSTER POINT BLVD. SOUTH SAN FRANCISCO, CA 94080 US Other 510(k) Applications for this Company
Contact	NINA PELED Other 510(k) Applications for this Contact
Regulation Number	866.5600   More FDA Info for this Regulation Number
Classification Product Code	NOE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2010
Decision Date	01/03/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review