
Maine Standards Co.
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VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET is an FDA 510(k)-cleared medical device (K091225) manufactured by Maine Standards Co.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 24, 2009. Regulation: 8.