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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 K112172
Model M100
Device Name QUIDEL MOLECULAR INFLUENZA A + B ASSAY
Original Applicant
QUIDEL CORP.
10165 mckellar ct.
san diego,  CA  92121
Original Contact ronald lollar
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Code
OOI  
Date Received07/28/2011
Decision Date 12/22/2011
Decision substantially equivalent - CLIA submission (CS)
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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