PLAC TEST FOR LP-PLA2 ACTIVITY

Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2

DIADEXUS, INC.

The following data is part of a premarket notification filed by Diadexus, Inc. with the FDA for Plac Test For Lp-pla2 Activity.

Pre-market Notification Details

Device IDK141575
510k NumberK141575
Device Name:PLAC TEST FOR LP-PLA2 ACTIVITY
ClassificationTest, System, Immunoassay, Lipoprotein-associated Phospholipase A2
Applicant DIADEXUS, INC. 3 LAGOON DR. SUITE 280 Redwood Shores,  CA  94065
ContactLorry Weaver Huffman
CorrespondentLorry Weaver Huffman
DIADEXUS, INC. 3 LAGOON DR. SUITE 280 Redwood Shores,  CA  94065
Product CodeNOE  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number866.5600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-12
Decision Date2014-12-15
Summary:summary

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