510(k) K023047

AMEDICA DRUG SCREEN OPIATES TEST by Amedica Biotech, Inc. — Product Code DJG

K023047 is an FDA 510(k) premarket notification submitted by Amedica Biotech, Inc. for the device "AMEDICA DRUG SCREEN OPIATES TEST". The FDA issued a decision of Substantially Equivalent on November 6, 2002. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Amedica Biotech, Inc. has at least 10 other 510(k) clearances on record.