510(k) K952096

ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) by Tcpi, Inc. — Product Code DJG

K952096 is an FDA 510(k) premarket notification submitted by Tcpi, Inc. for the device "ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE)". The FDA issued a decision of Substantially Equivalent on August 17, 1995. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Tcpi, Inc. has at least 10 other 510(k) clearances on record.