CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Beckman Coulter, Inc. Unicel Dxi 800 Access Immunoassay System   Document Number K083867 Analyte Name Sex Hormone Binding Globulin Analyte Specialty Endocrinology Complexity MODERATE Effective Date 09/01/2009 Device Classification Name radioimmunoassay, testosterones and dihydrotestosterone 510(k) Number K083867 Device Name ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND Applicant BECKMAN COULTER, INC. 1000 lake hazeltine dr. chaska,  MN  55318 108 Contact tyler foutch Regulation Number 862.1680 Classification Product Code CDZ   Subsequent Product Codes JIT   JJX   Date Received 12/29/2008 Decision Date 08/27/2009 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