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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 K062234
Device Name MODIFICATION TO DIADEXUS PLAC TEST
Applicant
DIADEXUS, INC.
343 OYSTER POINT BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Applicant Contact ROBERT L WOLFERT
Correspondent
DIADEXUS, INC.
343 OYSTER POINT BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Correspondent Contact ROBERT L WOLFERT
Regulation Number866.5600
Classification Product Code
NOE  
Date Received08/02/2006
Decision Date 09/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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