510(k) K053035

ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 by Acro Biotech, LLC — Product Code DIO

K053035 is an FDA 510(k) premarket notification submitted by Acro Biotech, LLC for the device "ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000". The FDA issued a decision of Substantially Equivalent on May 5, 2006. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Acro Biotech, LLC has at least 9 other 510(k) clearances on record.