510(k) K022693

INSTANT-VIEW TCA URINE TEST by Alfa Scientific Designs, Inc. — Product Code MLK

K022693 is an FDA 510(k) premarket notification submitted by Alfa Scientific Designs, Inc. for the device "INSTANT-VIEW TCA URINE TEST". The FDA issued a decision of Substantially Equivalent on December 9, 2002. The device falls under product code MLK (Thin Layer Chromatography, Tricyclic Antidepressant Drugs), a Class II device regulated under 21 CFR 862.3910. Alfa Scientific Designs, Inc. has at least 10 other 510(k) clearances on record.