CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Omnis Health Embrace No Code Blood Glucose Monitoring System   Document Number K090043 Analyte Name Glucose Monitoring Devices (FDA Cleared/Home Use) Analyte Specialty General Chemistry Complexity WAIVED Effective Date 09/01/2009 Device Classification Name glucose oxidase, glucose 510(k) Number K090043 Device Name AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9 Applicant APEX BIOTECHNOLOGY CORP. no. 7, li-hsin road v, hsinchu science park hsinchu,  Contact thomas y.s. shen Regulation Number 862.1345 Classification Product Code CGA   Subsequent Product Codes JJX   NBW   Date Received 01/13/2009 Decision Date 04/09/2009 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 Special Reviewed by Third Party No Expedited Review No