CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Fora Care Inc. FORA G30 Blood Glucose Monitoring System   Document Number K090187 Analyte Name Glucose Monitoring Devices (FDA Cleared/Home Use) Analyte Specialty General Chemistry Complexity WAIVED Effective Date 05/29/2009 Device Classification Name system, test, blood glucose, over the counter 510(k) Number K090187 Device Name FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 Applicant TAIDOC TECHNOLOGY CORPORATION 6f, no. 127, wugong 2nd rd wugu township taipei county,  Contact yuhua chen Regulation Number 862.1345 Classification Product Code NBW   Subsequent Product Code CGA   Date Received 01/26/2009 Decision Date 05/12/2009 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