MODIFICATION TO DIADEXUS PLAC TEST

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 Modification To Diadexus Plac Test.

Pre-market Notification Details

Device IDK062234
510k NumberK062234
Device Name:MODIFICATION TO DIADEXUS PLAC TEST
ClassificationTest, System, Immunoassay, Lipoprotein-associated Phospholipase A2
Applicant DIADEXUS, INC. 343 OYSTER POINT BLVD. South San Francisco,  CA  94080
ContactRobert L Wolfert
CorrespondentRobert L Wolfert
DIADEXUS, INC. 343 OYSTER POINT BLVD. South San Francisco,  CA  94080
Product CodeNOE  
CFR Regulation Number866.5600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-02
Decision Date2006-09-11
Summary:summary

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