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Medical device / Immunoassay / Premarket approval / CA19-9 / Federal Food /  Drug /  and Cosmetic Act / Center for Devices and Radiological Health / Quality management system / Medicine / Food and Drug Administration / Health
Date: 2011-05-30 00:42:58
Medical device
Immunoassay
Premarket approval
CA19-9
Federal Food
Drug
and Cosmetic Act
Center for Devices and Radiological Health
Quality management system
Medicine
Food and Drug Administration
Health

510(k) Summary of Safety and Effectiveness for the LOCI CA[removed]CA19-9) Flex® Reagent Cartridge APR Dimension Vista® LOCI 7 Calibrator

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