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Reametrix, Inc.
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TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00 is an FDA 510(k)-cleared medical device (K082091) manufactured by Reametrix, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 14, 2009. Regulation: 8.