
Sigma Diagnostics, Inc.
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ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III is an FDA 510(k)-cleared medical device (K932067) manufactured by Sigma Diagnostics, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 15, 1993. Regulation: 8.