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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name zika virus serological reagents
510(k) Number K191578
Device Name ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
Applicant
Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
tarrytown,  NY  10591
Applicant Contact matthew gee
Correspondent
Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
tarrytown,  NY  10591
Correspondent Contact matthew gee
Regulation Number866.3935
Classification Product Code
QFO  
Subsequent Product Code
QCH  
Date Received06/14/2019
Decision Date 07/17/2019
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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