510(k) K100108

AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA by Amedica Biotech, Inc. — Product Code NGL

K100108 is an FDA 510(k) premarket notification submitted by Amedica Biotech, Inc. for the device "AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA". The FDA issued a decision of Substantially Equivalent on April 14, 2010. The device falls under product code NGL (Test, Opiates, Over The Counter), a Class II device regulated under 21 CFR 862.3650. Amedica Biotech, Inc. has at least 10 other 510(k) clearances on record.