CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name RESPONSE BIOMEDICAL CORP., RAMP 200 READER   Document Number K091235 Analyte Name Respiratory Syncytial Virus Analyte Specialty Virology Complexity MODERATE Effective Date 08/07/2009 Device Classification Name antigen, cf (including cf controls), respiratory syncytial virus 510(k) Number K091235 Device Name RAMP RSV ASSAY Applicant RESPONSE BIOMEDICAL CORP. 1781 - 75th avenue w. vancouver, b.c,  Contact ken pilgrim Regulation Number 866.3480 Classification Product Code GQG   Date Received 04/27/2009 Decision Date 07/24/2009 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Microbiology Review Advisory Committee Microbiology Statement/Summary/Purged Status Summary only summary summary FDA Review Decision Summary Type Traditional Reviewed by Third Party No Expedited Review No