510(k) K053359

RAPIDTOX by American Bio Medica Corp. — Product Code DKZ

K053359 is an FDA 510(k) premarket notification submitted by American Bio Medica Corp. for the device "RAPIDTOX". The FDA issued a decision of Substantially Equivalent on May 25, 2006. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. American Bio Medica Corp. has at least 10 other 510(k) clearances on record.