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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 K192046
Device Name LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
Applicant
DiaSorin Inc.
1951 Northwestern Ave.
Stillwater,  MN  55082 -0285
Applicant Contact John C. Walter
Correspondent
DiaSorin Inc.
1951 Northwestern Avenue
Stillwater,  MN  55082 -0285
Correspondent Contact Sandra Zimniewicz
Regulation Number866.3935
Classification Product Code
QFO  
Date Received07/31/2019
Decision Date 10/28/2019
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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