510(k) K990681

DBSET MULTIDRUG SCREEN TEST KIT by Ameritek, Inc. — Product Code DKZ

K990681 is an FDA 510(k) premarket notification submitted by Ameritek, Inc. for the device "DBSET MULTIDRUG SCREEN TEST KIT". The FDA issued a decision of Substantially Equivalent on July 15, 1999. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Ameritek, Inc. has at least 10 other 510(k) clearances on record.