CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Siemens Advia 1200   Document Number K083906 Analyte Name Cystatin C Analyte Specialty General Chemistry Complexity MODERATE Effective Date 03/16/2009 Device Classification Name test, cystatin c 510(k) Number K083906 Device Name ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 Applicant SIEMENS HEALTHCARE DIAGNOSTICS 511 benedict avenue tarrytown,  NY  10591 Contact kira gordon Regulation Number 862.1225 Classification Product Code NDY   Subsequent Product Code JIT   Date Received 12/30/2008 Decision Date 03/11/2009 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Clinical Chemistry Review Advisory Committee Clinical Chemistry Statement/Summary/Purged Status Summary only summary summary FDA Review Decision Summary Type Traditional Reviewed by Third Party No Expedited Review No