RAMP TROPONIN I ASSAY

Immunoassay Method, Troponin Subunit

RESPONSE BIOMEDICAL CORP.

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

Pre-market Notification Details

Device IDK033745
510k NumberK033745
Device Name:RAMP TROPONIN I ASSAY
ClassificationImmunoassay Method, Troponin Subunit
Applicant RESPONSE BIOMEDICAL CORP. 8081 LOUGHEED HWY. Burnaby, British Columbia,  CA V5a 1w9
ContactWilliam J Radvak
CorrespondentWilliam J Radvak
RESPONSE BIOMEDICAL CORP. 8081 LOUGHEED HWY. Burnaby, British Columbia,  CA V5a 1w9
Product CodeMMI  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-01
Decision Date2004-05-17
Summary:summary

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