CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Abbott Architect c4000 system   Document Number K083809 Analyte Name Creatinine Analyte Specialty General Chemistry Complexity MODERATE Effective Date 09/16/2009 Device Classification Name alkaline picrate, colorimetry, creatinine 510(k) Number K083809 Device Name CREATININE Applicant ABBOTT LABORATORIES 1921 hurd dr. irving,  TX  75038 Contact linda morris Regulation Number 862.1225 Classification Product Code CGX   Date Received 12/22/2008 Decision Date 04/07/2009 Decision substantially equivalent (SE) Classification Advisory Committee Clinical Chemistry Review Advisory Committee Clinical Chemistry Statement/Summary/Purged Status Summary only summary summary FDA Review Decision Summary Type Special Reviewed by Third Party No Expedited Review No