510(k) K153301— Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II

Substantially Equivalent

Roche Diagnostics

Clearance details

Applicant: Roche Diagnostics
Product code: Code KXT
Advisory panel: Clinical Toxicology
Date received: 2015-11-13
Decision date: 2016-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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