510(k) K040629

ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE by Accu-Stat Diagnostics, Inc. — Product Code LDJ

K040629 is an FDA 510(k) premarket notification submitted by Accu-Stat Diagnostics, Inc. for the device "ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE". The FDA issued a decision of Substantially Equivalent on May 5, 2004. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Accu-Stat Diagnostics, Inc. has at least 2 other 510(k) clearances on record.