510(k) K131811

UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS by Ucp Biosciences, Inc. — Product Code DKZ

K131811 is an FDA 510(k) premarket notification submitted by Ucp Biosciences, Inc. for the device "UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS". The FDA issued a decision of Substantially Equivalent on July 19, 2013. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Ucp Biosciences, Inc. has at least 10 other 510(k) clearances on record.