510(k) K131645

INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) by Alfa Scientific Designs, Inc. — Product Code DKZ

K131645 is an FDA 510(k) premarket notification submitted by Alfa Scientific Designs, Inc. for the device "INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)". The FDA issued a decision of Substantially Equivalent on October 7, 2013. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Alfa Scientific Designs, Inc. has at least 10 other 510(k) clearances on record.