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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hepatitis a test (antibody and igm antibody)
510(k) Number K190428
Device Name Elecsys Anti-HAV II
Applicant
Roche Diagnostics
9115 Hague Road, PO Box 50416
Indianapolis,  IN  46250
Applicant Contact Jamie Ferguson
Correspondent
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Correspondent Contact Jamie Ferguson
Regulation Number866.3310
Classification Product Code
LOL  
Subsequent Product Code
QCH  
Date Received02/22/2019
Decision Date 08/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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