510(k) K974818

ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM by Radiometer America, Inc. — Product Code MMI

K974818 is an FDA 510(k) premarket notification submitted by Radiometer America, Inc. for the device "ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 16, 1998. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. Radiometer America, Inc. has at least 10 other 510(k) clearances on record.