CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Siemens IMMULITE 2000  {3gAllergy Specific IgE} (quantitative) Document Number K083853 Analyte Name Allergen Specific IgE Analyte Specialty General Immunology Complexity MODERATE Effective Date 04/01/2009 Device Classification Name system, test, radioallergosorbent (rast) immunological 510(k) Number K083853 Device Name IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT Applicant SIEMENS HEALTHCARE DIAGNOSTICS 511 benedict avenue tarrytown,  NY  10591 Contact clare santulli Regulation Number 866.5750 Classification Product Code DHB   Date Received 12/24/2008 Decision Date 03/24/2009 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