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FDA 510(k) Application Details - K050523
Device Classification Name
Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
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510(K) Number
K050523
Device Name
Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
Applicant
DIADEXUS, INC.
343 OYSTER POINT BLVD.
SOUTH SAN FRANCISCO, CA 94080 US
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Contact
Julie Blacklock
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Regulation Number
866.5600
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Classification Product Code
NOE
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Date Received
03/02/2005
Decision Date
06/15/2005
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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