510(k) K981197

ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST by Tcpi, Inc. — Product Code DKZ

K981197 is an FDA 510(k) premarket notification submitted by Tcpi, Inc. for the device "ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST". The FDA issued a decision of Substantially Equivalent on June 16, 1998. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Tcpi, Inc. has at least 10 other 510(k) clearances on record.