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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 K122189
Model M103
Device Name QUIDEL MOLECULAR RSV + 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  
Subsequent Product Code
OCC  
Date Received07/24/2012
Decision Date 03/08/2013
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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