CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Home Diagnostics, TRUEbalance Blood Glucose Monitoring System   Document Number K090495 Analyte Name Glucose Monitoring Devices (FDA Cleared/Home Use) Analyte Specialty General Chemistry Complexity WAIVED Effective Date 04/30/2009 Device Classification Name system, test, blood glucose, over the counter 510(k) Number K090495 Device Name TRUEBALANCE BLOOD GLUCOSE SYSTEM Applicant HOME DIAGNOSTICS, INC. 2400 n.w. 55th ct. fort lauderdale,  FL  33309 Contact karen devincent Regulation Number 862.1345 Classification Product Code NBW   Subsequent Product Code CGA   Date Received 02/25/2009 Decision Date 03/27/2009 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Clinical Chemistry Review Advisory Committee Clinical Chemistry Statement/Summary/Purged Status Statement only statement statement FDA Review Decision Summary Type Special Reviewed by Third Party No Expedited Review No