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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 K131728
Device Name QUIDEL MOLECULAR INFLUENZA A + B ASSAY
Applicant
QUIDEL CORP.
10165 MCKELLAR CT.
SAN DIEGO,  CA  92121
Applicant Contact Ronald H Lollar
Correspondent
QUIDEL CORP.
10165 MCKELLAR CT.
SAN DIEGO,  CA  92121
Correspondent Contact Ronald H Lollar
Regulation Number866.3980
Classification Product Code
OZE  
Subsequent Product Code
OOI  
Date Received06/12/2013
Decision Date 08/29/2013
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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