CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Epocal Inc., EPOC System   Document Number K090109 Analyte Name Glucose Analyte Specialty General Chemistry Complexity MODERATE Effective Date 09/16/2009 Device Classification Name glucose oxidase, glucose 510(k) Number K090109 Device Name BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD Applicant EPOCAL, INC. 2060 walkley rd. ottawa, ontario,  Contact roy layer Regulation Number 862.1345 Classification Product Code CGA   Date Received 01/15/2009 Decision Date 06/24/2009 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