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Laboratory techniques / Cardiology / Lipoproteins / Low-density lipoprotein / Triglyceride / Assay / Medical device / Chemistry / Medicine / Biology


NOV 2r2[removed]k) Summary of Safety and Effectiveness AD VIA® 1800 Chemistry Triglycerides 2 Reagents (TRIG 2) This summary of 510(k) safety and effectiveness information is being submitted in accordance with the req
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Document Date: 2013-12-09 11:45:54

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File Size: 270,25 KB

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City

St. Louis / Tarrytown / /

Company

Clinical Chemistry Manufacturer Siemens Healthcare Diagnostics Inc. / dL Siemens Healthicare Diagnostics Inc. / Plasma Siemens Heatlhcare Diagnostics Inc. / In Vitro Diagnostics / Siemens Healthcare Diagnostics Inc. / toIleaIy / K133067 Trade / Siemens Healthicare Diagnostics Inc / Sr. Regulatory Affairs Specialist Siemens Healthcare Diagnostics Inc / /

Event

FDA Phase / /

Facility

Laboratory Tests / National Institute of Standards and Technology / /

IndustryTerm

Internet address htto /

MedicalCondition

endocrine disorders / diabetes mellitus / diseases / nephrosis / /

Organization

National Institute of Standards and Technology / Center for Devices and Radiological Health / Radiological Health Center for Devices and Radiological Health Enclosure / CDRH 's office of Surveillance / FDA / Chemistry and ToxicologyDevices Office / Division of Postniarket Surveillance / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Division of Chemistry / /

Person

Ruth A. Chesler / SID CV / Kira Gordon / PhD Sr. / Courtney H. Lias / IRA GORDON / PH.D. SR. / /

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Position

SR. REGULATORY AFFAIRS SPECIALIST / Director / Set-Point Chemistry calibrator / calibrator / Chemistry Calibrator / /

Product

Cl / Federal Food / EP5-A2 / ADVIA / Evaluation / ADVIA® Chemistry TRIG / A2 / EP7-A2 / /

ProvinceOrState

Missouri / New York / /

Technology

radiation / http / /

URL

http /

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