510(k) K061005

ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS by Applied Dna Technologies, Inc. — Product Code DKZ

K061005 is an FDA 510(k) premarket notification submitted by Applied Dna Technologies, Inc. for the device "ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS". The FDA issued a decision of Substantially Equivalent on October 4, 2006. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Applied Dna Technologies, Inc. has at least 3 other 510(k) clearances on record.