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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 K031899
Device Name QUICKVUE INFLUENZA A+B TEST
Applicant
QUIDEL CORP.
10165 MCKELLAR CT.
SAN DIEGO,  CA  92121
Applicant Contact Robin Weiner
Correspondent
QUIDEL CORP.
10165 MCKELLAR CT.
SAN DIEGO,  CA  92121
Correspondent Contact Robin Weiner
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received06/04/2003
Decision Date 09/11/2003
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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