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FDA 510(k) Application Details - K063662
Device Classification Name
Test,Natriuretic Peptide
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
862.1117
More FDA Info for this Regulation Number
Classification Product Code
NBC
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More FDA Info for this Product Code
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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