510(k) K060896

MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT by Varian, Inc. — Product Code DJC

K060896 is an FDA 510(k) premarket notification submitted by Varian, Inc. for the device "MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT". The FDA issued a decision of Substantially Equivalent on June 9, 2006. The device falls under product code DJC (Thin Layer Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Varian, Inc. has at least 4 other 510(k) clearances on record.