510(k) K951853

ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) by Tcpi, Inc. — Product Code LDJ

K951853 is an FDA 510(k) premarket notification submitted by Tcpi, Inc. for the device "ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)". The FDA issued a decision of Substantially Equivalent on August 20, 1996. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Tcpi, Inc. has at least 10 other 510(k) clearances on record.