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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices Detecting Influenza A, B, And C Virus Antigens
510(k) Number K180288
Device Name QuickVue Influenza A+B
Applicant
Quidel Corporation
10165 Mckellar Ct.
San Diego,  CA  92121
Applicant Contact Jennifer S. Rial
Correspondent
Quidel Corporation
10165 Mckellar Ct.
San Diego,  CA  92121
Correspondent Contact Jennifer S. Rial
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received02/01/2018
Decision Date 02/13/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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