510(k) K151213

UCP Drug Test Mini Cups by Ucp Biosciences, Inc. — Product Code DKZ

K151213 is an FDA 510(k) premarket notification submitted by Ucp Biosciences, Inc. for the device "UCP Drug Test Mini Cups". The FDA issued a decision of Substantially Equivalent on August 21, 2015. 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.