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Siemens Healthcare Diagnostics
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ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 is an FDA 510(k)-cleared medical device (K100200) manufactured by Siemens Healthcare Diagnostics. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 1, 2010. Regulation: 8.