RAMP INFLUENZA A/B ASSAY

Devices Detecting Influenza A, B, And C Virus Antigens

RESPONSE BIOMEDICAL CORP.

The following data is part of a premarket notification filed by Response Biomedical Corp. with the FDA for Ramp Influenza A/b Assay.

Pre-market Notification Details

Device IDK071591
510k NumberK071591
Device Name:RAMP INFLUENZA A/B ASSAY
ClassificationDevices Detecting Influenza A, B, And C Virus Antigens
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 CodePSZ  
CFR Regulation Number866.3328 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-06-11
Decision Date2008-04-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10627966005244 K071591 000
10627966005237 K071591 000

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