510(k) K023104

AMEDICA DRUG SCREEN AMPHETAMINE TEST by Amedica Biotech, Inc. — Product Code DKZ

K023104 is an FDA 510(k) premarket notification submitted by Amedica Biotech, Inc. for the device "AMEDICA DRUG SCREEN AMPHETAMINE TEST". The FDA issued a decision of Substantially Equivalent on December 16, 2002. 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.