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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Digoxin
510(k) Number K193397
Device Name ADVIA Centaur® Digoxin assay
Applicant
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact Anoop Joy
Correspondent
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact Anoop Joy
Regulation Number862.3320
Classification Product Code
KXT  
Date Received12/06/2019
Decision Date 07/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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