FDA 510(k) Application Details - K063662

Device Classification Name Test,Natriuretic Peptide

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510(K) Number K063662
Device Name Test,Natriuretic Peptide
Applicant RESPONSE BIOMEDICAL CORP.
100 - 8900 GLENLYON PARKWAY
BURNABY, BRITISH COLUMBIA V5J 5J8 CA
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Contact KEN PILGRIM
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Regulation Number 862.1117

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Classification Product Code NBC
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Date Received 12/08/2006
Decision Date 07/21/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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