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Fibrin degradation product / Fibrinolysis / D-dimer / Blood tests / Coagulation system / Biology


510(k) Summary ~~t This summary of 5 10(k) safety and effectiveness information is being submitted in accordance
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Document Date: 2013-06-25 11:42:22

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City

Poway / /

Company

Lg / In Vitro Diagnostics / /

Facility

Gregg Court / Laboratory Standards Institute EP6 / New Hampshire Avenue Document Control Center / /

/

Holiday

between day / /

IndustryTerm

fibrinogen/fibrin degradation products / predicate device / manufacturing / fibrin degradation products / /

Organization

Food and Drug Administration / Gregg Court / ded / DEPARTMENT OF HEALTH / /

Person

Maria M. Chan / Cosmetic Act (Act) / Abhij / Abhijit Datta / /

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Position

Director / Calibrator / Major / mL Calibrator / Control JIT Calibrator / Device D-Dimer Assay Kit D-Dimer Assay Calibrator / / saline calibrator Calibrator / Diazyme D-Dimer Calibrator / /

ProvinceOrState

California / /

Technology

radiation / antibodies / /

URL

http /

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