FDA 510(k) Application Details - K141575

Device Classification Name Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

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510(K) Number K141575
Device Name Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
Applicant DIADEXUS, INC.
3 LAGOON DR. SUITE 280
REDWOOD SHORES, CA 94065 US
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Contact Lorry Weaver Huffman
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Regulation Number 866.5600

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Classification Product Code NOE
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Date Received 06/12/2014
Decision Date 12/15/2014
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



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