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Chromsystems Instruments & Chemicals GmbH
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CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS is an FDA 510(k)-cleared medical device (K080459) manufactured by Chromsystems Instruments & Chemicals GmbH. This device is classified under the Clinical Toxicology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 16, 2009. Regulation: 8.