510(k) K053032

ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000 by Acro Biotech, LLC — Product Code DKZ

K053032 is an FDA 510(k) premarket notification submitted by Acro Biotech, LLC for the device "ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000". The FDA issued a decision of Substantially Equivalent on February 9, 2006. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Acro Biotech, LLC has at least 9 other 510(k) clearances on record.