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Immunoassay / Phospholipase A2 / Lipoprotein-associated phospholipase A2 / ELISA / Medical device / Cardiovascular disease / Lipoprotein / Premarket approval / Atherosclerosis / Medicine / Immunologic tests / Peripheral membrane proteins


R oS5 510(k) Summary 1.0 Submitted By:
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Document Date: 2011-02-17 14:36:01

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File Size: 169,53 KB

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City

South San Francisco / /

Company

MD 20993 diaDexus Inc. / /

Event

FDA Phase / /

Facility

New Hampshire Avenue Building / /

/

IndustryTerm

test systems / appropriate calibration curve fitting software / Internet address hittp /

MedicalCondition

atherosclerosis / ischemic stroke / ischemnic stroke / coronary heart disease / /

Organization

CodeHapr Ph.D. Director Division of Chemistry / Division Sign-Off Office / Division of Postmarket Surveillance / In Vitro Diagnostic Device Evaluation and Safety Center for Devices / FDA / DEPARTMENT OF HEALTH &HUMAN SERVICES Public Health Service Food & Drug Administration / Division of Small Manufacturers / International and Consumer Assistance / CDRH's office of Surveillance / /

Person

Silver Spring / Nina Peled / Lynne McBride / /

/

Position

same Differences Item Measuring range Methodology Reagent Configuration Kit Configuration Calibrator / Director of Regulatory Affairs diaDexus / Consultant / /

Product

R2 Suspension / Federal Food / /

ProvinceOrState

California / /

Technology

antibodies / turbidimetric immunoassay technology / /

URL

www.fda.y~ov/MedicalDevices/Safety/ReportaProblem/jdefaulthtm / /

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