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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Natriuretic Peptide
510(k) Number K063662
Device Name RAMP NT-PROBNP 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 Number862.1117
Classification Product Code
NBC  
Date Received12/08/2006
Decision Date 07/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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