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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


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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Document Date: 2011-05-30 00:42:58

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File Size: 191,37 KB

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