CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Luminex 100 Integrated System  {xTAG Cystic Fibrosis 39 Kit v2}  Document Number K083846 Analyte Name CFTR (cystic fibrosis transmembrane conductance regulator) mutations Analyte Specialty General Immunology Complexity HIGH Effective Date 09/09/2009 Device Classification Name system, cystic fibrosis transmembrane conductance regulator, gene mutation detection 510(k) Number K083846 Device Name XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 Applicant LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 university ave. toronto, ontario,  Contact gloria lee Regulation Number 866.5900 Classification Product Code NUA   Date Received 12/24/2008 Decision Date 09/01/2009 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Immunology Review Advisory Committee Immunology Statement/Summary/Purged Status Summary only summary summary FDA Review Decision Summary Type Traditional Reviewed by Third Party No Expedited Review No