CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name EUROIMMUN ANCA IFA Granulocyte BIOCHIP Mosaic Test System  {Anti-PR3 and anti-MPO antigen dots}  Document Number K083850 Analyte Name ANTI-NEUTROPHIL CYTOPLASM ANTIBODIES (ANCA) Analyte Specialty General Immunology Complexity HIGH Effective Date 05/21/2009 Device Classification Name test system, antineutrophil cytoplasmic antibodies (anca) 510(k) Number K083850 Device Name EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS Applicant EUROIMMUN US INC 95 washington st morristown,  NJ  07960 Contact kathryn kohl Regulation Number 866.5660 Classification Product Code MOB   Date Received 12/24/2008 Decision Date 05/20/2009 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Immunology Review Advisory Committee Immunology Statement/Summary/Purged Status Statement only FDA Review Decision Summary Type Traditional Reviewed by Third Party No Expedited Review No