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K123677 - Accessdata FDA - Food and Drug Administration

K123677 - Accessdata FDA - Food and Drug Administration 2025

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The document is a 510(k) summary for the Dimension Vista® Ammonia Flex® reagent cartridge (AMM) and the Dimension Vista® Chem 3 Calibrator (CHEM 3 CAL), submitted by Siemens Healthcare Diagnostics. It outlines the safety and effectiveness of these in vitro diagnostic devices for measuring ammonia levels in human plasma, which are critical for diagnosing severe liver disorders. The summary includes regulatory information, device descriptions, intended uses, performance characteristics, and substantial equivalence to predicate devices.

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K123677 - Accessdata FDA - Food and Drug Administration 2025

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