CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Abbott i-STAT CHEM8+ Catridge  (Venous Whole blood) Document Number K053110 Analyte Name Calcium, Ionized Analyte Specialty General Chemistry Complexity WAIVED Effective Date 09/21/2007 Device Classification Name electrode, ion specific, sodium 510(k) Number K053110 Device Name I-STAT CHEM8 + CARTRIDGE Applicant I-STAT CORPORATION 104 windsor center drive east windsor,  NJ  08520 Contact paul vanderwerf Regulation Number 862.1665 Classification Product Code JGS   Subsequent Product Codes CDS   CEM   CGA   CGL   CGZ   JFL   JFP   JPI   Date Received 11/04/2005 Decision Date 01/13/2006 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 CLIA Waiver CLIA Waiver Decision Summary Type Special Reviewed by Third Party No Expedited Review No