510(k) K063379

AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220 by Amedica Biotech, Inc. — Product Code DKZ

K063379 is an FDA 510(k) premarket notification submitted by Amedica Biotech, Inc. for the device "AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220". The FDA issued a decision of Substantially Equivalent on December 11, 2006. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Amedica Biotech, Inc. has at least 10 other 510(k) clearances on record.