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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name respiratory virus panel nucleic acid assay system
510(k) Number K131813
Device Name QUIDEL MOLECULAR RSV + HMPV 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
OCC  
Subsequent Product Code
OEM  
Date Received06/20/2013
Decision Date 09/06/2013
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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