CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Instrumentation Laboratory (IL) TOP  {Hemosil Liquid Heparin}  Document Number K090209 Analyte Name Heparin Analyte Specialty Hematology Complexity HIGH Effective Date 06/03/2009 Device Classification Name assay, heparin 510(k) Number K090209 Device Name HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS Applicant INSTRUMENTATION LABORATORY CO. 113 hartwell ave. lexington,  MA  02421 Contact carol marble Regulation Number 864.7525 Classification Product Code KFF   Subsequent Product Codes GGN   JIS   Date Received 01/28/2009 Decision Date 06/02/2009 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Hematology Review Advisory Committee Hematology Statement/Summary/Purged Status Summary only summary summary FDA Review Decision Summary Type Traditional Reviewed by Third Party No Expedited Review No