510(k) K912365

TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS by Abbott Laboratories — Product Code JXN

K912365 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS". The FDA issued a decision of Substantially Equivalent on August 16, 1991. The device falls under product code JXN (Enzyme Immunoassay, Propoxyphene), a Class II device regulated under 21 CFR 862.3700. Abbott Laboratories has at least 10 other 510(k) clearances on record.