
Maine Standards Company, LLC
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VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit is an FDA 510(k)-cleared medical device (K162705) manufactured by Maine Standards Company, LLC. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 4, 2017. Regulation: 8.