
Icn Biomedicals, Inc.
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RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 is an FDA 510(k)-cleared medical device (K030211) manufactured by Icn Biomedicals, 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 June 12, 2003. Regulation: 8.