Cleared Traditional

ADVIA Centaur? Digoxin assay

K193397 · Siemens Healthcare Diagnostics, Inc. · Toxicology
Jul 2021
Decision
588d
Days
Class 2
Risk

About This 510(k) Submission

K193397 is an FDA 510(k) clearance for the ADVIA Centaur? Digoxin assay, a Enzyme Immunoassay, Digoxin (Class II — Special Controls, product code KXT), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on July 16, 2021, 588 days after receiving the submission on December 6, 2019. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K193397 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2019
Decision Date July 16, 2021
Days to Decision 588 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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