510(k) K983190

DBEST OPIATES TEST KIT by Ameritek, Inc. — Product Code DJG

K983190 is an FDA 510(k) premarket notification submitted by Ameritek, Inc. for the device "DBEST OPIATES TEST KIT". The FDA issued a decision of Substantially Equivalent on November 18, 1998. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Ameritek, Inc. has at least 10 other 510(k) clearances on record.