510(k) K030211

RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 by Icn Biomedicals, Inc. — Product Code DKX

K030211 is an FDA 510(k) premarket notification submitted by Icn Biomedicals, Inc. for the device "RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016". The FDA issued a decision of Substantially Equivalent on June 13, 2003. The device falls under product code DKX (Thin Layer Chromatography, Barbiturate), a Class II device regulated under 21 CFR 862.3150. Icn Biomedicals, Inc. has at least 10 other 510(k) clearances on record.