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510(k) Summary Introduction According to the requirements of 21 CFR[removed], the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
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Document Date: 2013-05-06 11:18:57

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File Size: 258,89 KB

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Company

CONTROLS Trade / ELITech Clinical Systems / In Vitro Diagnostics / Automated Systems / K130765 Trade / ELlrechgroup / CALIBRATOR Trade / ELiech Clinical Systems / /

Country

France / /

Facility

To store / New Hampshire Avenue Document Control Center / /

IndustryTerm

manufacturing / /

MedicalCondition

HIV / HCV / /

Organization

Food and Drug Administration / FDA / DEPARTMENT OF HEALTH / /

Person

Debra K. Hutson / Silver Spring / Courtney H. Lias / Cosmetic Act (Act) / /

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Position

Director / calibrator / Major / /

ProgrammingLanguage

EC / C / /

ProvinceOrState

Maryland / Washington / /

Technology

radiation / antibodies / ADO / /

URL

www.fda.gov/AbotitFDA/CenteisOffices/CDRH/CDRHOfices/ucli / www.fda.szov/MedicaIDevices/Safety/ReportaProblem/default.htm / www.fda.!4ov/medicalDevices/ResouircesforYou/Industrv/defauilt.htn / /

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