510(k) K061556

AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 by Amedica Biotech, Inc. — Product Code LDJ

K061556 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,; MODEL C1010,C1015,C1020". The FDA issued a decision of Substantially Equivalent on July 21, 2006. 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.