Cleared Traditional

Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II

K153301 · Roche Diagnostics · Chemistry
Apr 2016
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K153301 is an FDA 510(k) clearance for the Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II, a Enzyme Immunoassay, Digoxin (Class II — Special Controls, product code KXT), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on April 8, 2016, 147 days after receiving the submission on November 13, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K153301 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2015
Decision Date April 08, 2016
Days to Decision 147 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KXT — Enzyme Immunoassay, Digoxin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320

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