510(k) K121065

POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE by Polymed Therapeutics, Inc. — Product Code DKZ

K121065 is an FDA 510(k) premarket notification submitted by Polymed Therapeutics, Inc. for the device "POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE". The FDA issued a decision of Substantially Equivalent on May 24, 2013. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Polymed Therapeutics, Inc. has at least 4 other 510(k) clearances on record.