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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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More FDA Info for this Product Code
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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