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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name respiratory virus panel nucleic acid assay system
510(k) Number K102170
Device Name SIMPLEXA FLU A/B & RSV
Original Applicant
FOCUS DIAGNOSTICS, INC.
11331 valley view st
cypress,  CA  90630
Original Contact tara viviani
Regulation Number866.3980
Classification Product Code
OCC  
Date Received08/03/2010
Decision Date 11/24/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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