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Lumiquick Diagnostics, Inc.
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QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE is an FDA 510(k)-cleared medical device (K130213) manufactured by Lumiquick Diagnostics, Inc.. 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 October 17, 2013. Regulation: 8.