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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name human metapneumovirus (hmpv) rna assay system
510(k) Number K112490
Model M101
Device Name QUIDEL MOLECULAR HMPV ASSAY
Original Applicant
QUIDEL CORP.
10165 mckellar ct.
san diego,  CA  92121
Original Contact ronald h lollar
Regulation Number866.3980
Classification Product Code
OEM  
Date Received08/29/2011
Decision Date 12/15/2011
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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