510(k) K080872

AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ by Amedica Biotech, Inc. — Product Code LDJ

K080872 is an FDA 510(k) premarket notification submitted by Amedica Biotech, Inc. for the device "AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ". The FDA issued a decision of Substantially Equivalent on August 19, 2008. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Amedica Biotech, Inc. has at least 10 other 510(k) clearances on record.