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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
510(k) Number K072599
Device Name PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109
Applicant
DIADEXUS, INC.
343 OYSTER POINT BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Applicant Contact ROBERT WOLFERT PH.D
Correspondent
DIADEXUS, INC.
343 OYSTER POINT BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Correspondent Contact ROBERT WOLFERT PH.D
Regulation Number866.5600
Classification Product Code
NOE  
Subsequent Product Codes
JIT   JJX  
Date Received09/14/2007
Decision Date 12/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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