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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 K200506
Device Name DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
Applicant
Chembio Diagnostic Systems
3661 Horseblock Road
Medford,  NY  11763
Applicant Contact Louise Muscat Sigismondi
Correspondent
Chembio Diagnostic Systems
3661 Horseblock Road
Medford,  NY  11763
Correspondent Contact Louise Muscat Sigismondi
Regulation Number866.3935
Classification Product Code
QFO  
Subsequent Product Codes
JJQ   QCH  
Date Received03/02/2020
Decision Date 06/03/2020
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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