510(k) K153301

Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II by Roche Diagnostics — Product Code KXT

K153301 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II". The FDA issued a decision of Substantially Equivalent on April 8, 2016. The device falls under product code KXT (Enzyme Immunoassay, Digoxin), a Class II device regulated under 21 CFR 862.3320. Roche Diagnostics has at least 10 other 510(k) clearances on record.