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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Myoglobin, Antigen, Antiserum, Control
510(k) Number K012040
Device Name RAMP MYOGLOBIN ASSAY
Applicant
Response Biomedical Corp.
8855 Northbrook Ct.
Burnaby, British Columbia,  CA V5J 5J1
Applicant Contact WILLIAM J RADVAK
Correspondent
Response Biomedical Corp.
8855 Northbrook Ct.
Burnaby, British Columbia,  CA V5J 5J1
Correspondent Contact WILLIAM J RADVAK
Regulation Number866.5680
Classification Product Code
DDR  
Date Received06/29/2001
Decision Date 12/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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