510(k) K890792

POTASSIUM AND SODIUM ELECTROLYTE ANALYZER by Ionetics, Inc. — Product Code CEM

K890792 is an FDA 510(k) premarket notification submitted by Ionetics, Inc. for the device "POTASSIUM AND SODIUM ELECTROLYTE ANALYZER". The FDA issued a decision of Substantially Equivalent on May 3, 1989. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Ionetics, Inc. has at least 6 other 510(k) clearances on record.