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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 K153301
Device Name Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolos,  IN  46250
Applicant Contact EDIE EADS
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolos,  IN  46250
Correspondent Contact EDIE EADS
Regulation Number862.3320
Classification Product Code
KXT  
Subsequent Product Code
JJY  
Date Received11/13/2015
Decision Date 04/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
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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