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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Syncytial Virus - Elisa
510(k) Number K061008
Device Name QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199
Applicant
Quidel Corp.
10165 Mckellar Ct.
San Diego,  CA  92121
Applicant Contact JOHN D TAMERIUS
Correspondent
Quidel Corp.
10165 Mckellar Ct.
San Diego,  CA  92121
Correspondent Contact JOHN D TAMERIUS
Regulation Number866.3480
Classification Product Code
MCE  
Date Received04/12/2006
Decision Date 09/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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