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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
510(k) Number K091235
Device Name RAMP RSV ASSAY
Applicant
Response Biomedical Corp.
1781 - 75th Ave. W.
Vancouver, B.C,  CA V6P 6P2
Applicant Contact KEN PILGRIM
Correspondent
Response Biomedical Corp.
1781 - 75th Ave. W.
Vancouver, B.C,  CA V6P 6P2
Correspondent Contact KEN PILGRIM
Regulation Number866.3480
Classification Product Code
GQG  
Date Received04/27/2009
Decision Date 07/24/2009
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
Predetermined Change
Control Plan Authorized		 No
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