510(k) K932615

TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II by Abbott Laboratories — Product Code LAO

K932615 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II". The FDA issued a decision of Substantially Equivalent on July 14, 1993. The device falls under product code LAO (Enzyme Immunoassay, Methotrexate), a Class U device. Abbott Laboratories has at least 10 other 510(k) clearances on record.