CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Medonic M-Series Automatic Hematology Analyzer   Document Number K083420 Analyte Name White Blood Cell Differential (WBC Diff) Analyte Specialty Hematology Complexity MODERATE Effective Date 02/09/2009 Device Classification Name counter, differential cell 510(k) Number K083420 Device Name MEDONIC M SERIES Applicant BOULE MEDICAL AB 1800 n.w. 65th ave plantation,  FL  33313 Contact michael elliott Regulation Number 864.5220 Classification Product Code GKZ   Date Received 11/19/2008 Decision Date 02/03/2009 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Hematology Review Advisory Committee Hematology Statement/Summary/Purged Status Summary only FDA Review Decision Summary Type Special Reviewed by Third Party No Expedited Review No