ADVIA Centaur® Digoxin assay— 510(k) K193397

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K193397 for ADVIA Centaur® Digoxin assay, Substantially Equivalent on 2021-07-16. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code KXT
Advisory panel: Clinical Toxicology
Date received: 2019-12-06
Decision date: 2021-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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