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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 K071591
Device Name RAMP INFLUENZA A/B ASSAY
Applicant
Response Biomedical Corp.
100 - 8900 Glenlyon Pkwy.
Burnaby, British Columbia,  CA V5J 5J8
Applicant Contact KEN PILGRIM
Correspondent
Response Biomedical Corp.
100 - 8900 Glenlyon Pkwy.
Burnaby, British Columbia,  CA V5J 5J8
Correspondent Contact KEN PILGRIM
Regulation Number866.3328
Classification Product Code
PSZ  
Subsequent Product Code
KHO  
Date Received06/11/2007
Decision Date 04/16/2008
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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