VALIDATE Anemia Calibration Verification/ Linearity Test Kit

VALIDATE Anemia Calibration Verification/ Linearity Test Kit is an FDA 510(k)-cleared medical device (K142964) manufactured by Maine Standards Company, LLC. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 29, 2015. Regulation: 8.