RAMP NT-PROBNP ASSAY

Test, Natriuretic Peptide

RESPONSE BIOMEDICAL CORP.

The following data is part of a premarket notification filed by Response Biomedical Corp. with the FDA for Ramp Nt-probnp Assay.

Pre-market Notification Details

Device IDK063662
510k NumberK063662
Device Name:RAMP NT-PROBNP ASSAY
ClassificationTest, Natriuretic Peptide
Applicant RESPONSE BIOMEDICAL CORP. 100 - 8900 GLENLYON PARKWAY Burnaby, British Columbia,  CA V5j 5j8
ContactKen Pilgrim
CorrespondentKen Pilgrim
RESPONSE BIOMEDICAL CORP. 100 - 8900 GLENLYON PARKWAY Burnaby, British Columbia,  CA V5j 5j8
Product CodeNBC  
CFR Regulation Number862.1117 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-08
Decision Date2008-07-21
Summary:summary

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