CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Chempaq XBC Analyzer   Document Number K090013 Analyte Name White Blood Cell Count (Leukocyte Count) (WBC) Analyte Specialty Hematology Complexity MODERATE Effective Date 04/22/2009 Device Classification Name counter, differential cell 510(k) Number K090013 Device Name CHEMPAQ XBC ANALYZER Applicant CHEMPAQ A/S hirsemarken 1b farum,  Contact lone hoffensets Regulation Number 864.5220 Classification Product Code GKZ   Date Received 01/02/2009 Decision Date 04/21/2009 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 Special Reviewed by Third Party No Expedited Review No