CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Abbott Architect i 2000SR System  {Axis-Shield Diagnostics, Ltd}  Document Number K083868 Analyte Name Anti-Citrullinated Cyclic Peptide (Anti-Ccp) Analyte Specialty General Immunology Complexity MODERATE Effective Date 10/01/2009 Device Classification Name antibodies, anti-cyclic citrullinated peptide (ccp) 510(k) Number K083868 Device Name ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 Applicant AXIS-SHIELD DIAGNOSTICS, LTD. the technology park dundee, scotland,  Contact claire dora Regulation Number 866.5775 Classification Product Code NHX   Subsequent Product Codes JIX   JJY   Date Received 12/29/2008 Decision Date 09/25/2009 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Immunology Review Advisory Committee Immunology Statement/Summary/Purged Status Statement only FDA Review Decision Summary Type Traditional Reviewed by Third Party No Expedited Review No