510(k) K994405

INSTANT-VIEW MARIJUANA URINE CASSETTE TEST by Alfa Scientific Designs, Inc. — Product Code DKE

K994405 is an FDA 510(k) premarket notification submitted by Alfa Scientific Designs, Inc. for the device "INSTANT-VIEW MARIJUANA URINE CASSETTE TEST". The FDA issued a decision of Substantially Equivalent on June 2, 2000. The device falls under product code DKE (Reagents, Test, Tetrahydrocannabinol), a Class II device regulated under 21 CFR 862.3870. Alfa Scientific Designs, Inc. has at least 10 other 510(k) clearances on record.