510(k) K073157

VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 by Ortho-Clinical Diagnostics, Inc. — Product Code CEM

K073157 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2". The FDA issued a decision of Substantially Equivalent on December 7, 2007. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.