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Biology / Partial thromboplastin time / Thromboplastin / Coagulation / Lupus anticoagulant / Von Willebrand disease / Anticoagulant / Medical device / Plasma / Coagulation system / Medicine / Blood tests


510K SUMMARY-820 ASSAY ONLY TEMPLATE Kitox37
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Document Date: 2011-08-29 00:29:49

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File Size: 220,43 KB

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City

Bedford / /

Company

AOL / APTV / Instrumentation Laboratory Co. / Date Prepared Instrumentation Laboratory Co. / /

Country

United States / /

/

Event

Product Issues / FDA Phase / /

IndustryTerm

Internet address littp /

MedicalCondition

acquired deficiency / Lupus / Factor deficiency / /

Organization

In Vitro Diagnostic Device Evaluation and Safety Center for Devices / Food and Drug Administration / office of Surveillance / Immunology and Hematology Devices Office / New Hampshire Avenue Document Mail Center / FDA / Division of Immunology / AOIL TOP Family / Division of Small Manufacturers / International and Consumer Assistance / Division of Postmnarket Surveillance / Hematology Devices Office / /

Person

Maria M. Chan / Jacqueline Emery / /

/

Position

Manager July / BSEE Regulatory Affairs Manager / Director / Manager 180 Hartwell Rd. / Regulatory Affairs Manager / representative / /

Product

Federal Food / plasma Regulatory Information Regulation section / Plasma Regulation Number / predicate / G. / plasma / plasma Instrumentation Laboratory Co. / its predicate / /

ProvinceOrState

Massachusetts / /

Technology

antibodies / /

SocialTag