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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name anti-jcv antibody detection assay
510(k) Number K120986
Device Name STRATIFY JCV DXSELECT
Original Applicant
FOCUS DIAGNOSTICS, INC.
11331 valley view street
cypress,  CA  90630
Original Contact tara viviani
Regulation Number866.3336
Classification Product Code
OYP  
Date Received04/02/2012
Decision Date 08/16/2012
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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