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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name influenza a and influenza b multiplex nucleic acid assay
510(k) Number K113777
Device Name QUIDEL MOLECULAR INFLUENZA A+B
Original Applicant
QUIDEL CORP.
10165 mckellar ct.
san diego,  CA  92121
Original Contact ronald h lollar
Regulation Number866.3980
Classification Product Code
OZE  
Subsequent Product Code
OOI  
Date Received12/21/2011
Decision Date 03/15/2012
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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