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Maine Standards Co.
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VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 is an FDA 510(k)-cleared medical device (K033879) manufactured by Maine Standards Co.. 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 February 26, 2004. Regulation: 8.