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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 K141575
Device Name PLAC TEST FOR LP-PLA2 ACTIVITY
Applicant
Diadexus, Inc.
3 Lagoon Dr.
Suite 280
Redwood Shores,  CA  94065
Applicant Contact Lorry Weaver Huffman
Correspondent
Diadexus, Inc.
3 Lagoon Dr.
Suite 280
Redwood Shores,  CA  94065
Correspondent Contact Lorry Weaver Huffman
Regulation Number866.5600
Classification Product Code
NOE  
Subsequent Product Codes
JIT   JJX  
Date Received06/12/2014
Decision Date 12/15/2014
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
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