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Ab Sciex, LLC
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Vitamin D 200M Assay for the Topaz System is an FDA 510(k)-cleared medical device (DEN170019) manufactured by Ab Sciex, LLC. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 17, 2017. Regulation: 8.