510(k) K063545

MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE by Alfa Scientific Designs, Inc. — Product Code DJG

K063545 is an FDA 510(k) premarket notification submitted by Alfa Scientific Designs, Inc. for the device "MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE". The FDA issued a decision of Substantially Equivalent on May 7, 2007. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Alfa Scientific Designs, Inc. has at least 10 other 510(k) clearances on record.