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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name enzyme linked immunoabsorbent assay, cytomegalovirus
510(k) Number K163569
Device Name Elecsys CMV IgM
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact Angelo Pereira
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact Angelo Pereira
Regulation Number866.3175
Classification Product Code
Date Received12/19/2016
Decision Date 03/17/2017
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
Recalls CDRH Recalls