
Roche Diagnostics Corp.
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CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 is an FDA 510(k)-cleared medical device (K080183) manufactured by Roche Diagnostics Corp.. This device is classified under the Clinical Toxicology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 24, 2008. Regulation: 8.