PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109

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 Reagent Kit,calibrator Kit, Lp-pla2 Control Kit, Model(s) 90107,90109,90109.

Pre-market Notification Details

Device IDK072599
510k NumberK072599
Device Name:PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109
ClassificationTest, System, Immunoassay, Lipoprotein-associated Phospholipase A2
Applicant DIADEXUS, INC. 343 OYSTER POINT BLVD. South San Francisco,  CA  94080
ContactRobert Wolfert Ph.d
CorrespondentRobert Wolfert Ph.d
DIADEXUS, INC. 343 OYSTER POINT BLVD. South San Francisco,  CA  94080
Product CodeNOE  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number866.5600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-14
Decision Date2007-12-20
Summary:summary

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