510(k) K981504

DBEST AMPHETAMINES TEST KIT by Ameritek, Inc. — Product Code DKZ

K981504 is an FDA 510(k) premarket notification submitted by Ameritek, Inc. for the device "DBEST AMPHETAMINES TEST KIT". The FDA issued a decision of Substantially Equivalent on August 6, 1998. 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.