510(k) K903034

RENALYZER PRX 90 by Swedish Trade Council USA — Product Code CGL

K903034 is an FDA 510(k) premarket notification submitted by Swedish Trade Council USA for the device "RENALYZER PRX 90". The FDA issued a decision of Substantially Equivalent on March 13, 1991. The device falls under product code CGL (Electrode, Ion Based, Enzymatic, Creatinine), a Class II device regulated under 21 CFR 862.1225. Swedish Trade Council USA has at least 1 other 510(k) clearance on record.