CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer   Document Number K070929 Analyte Name Urine Qualitative Dipstick pH Analyte Specialty Urinalysis Complexity WAIVED Effective Date 10/28/2009 Device Classification Name automated urinalysis system 510(k) Number K070929 Device Name ACON U120 URINE ANALYZER, MODEL U111-101 Applicant ACON LABORATORIES, INC. 4139 gardendale center, #101 san antonio,  TX  78229 Contact martin o'connor Regulation Number 862.2900 Classification Product Code KQO   Subsequent Product Codes CDM   CEN   JIL   JIN   JIO   JIR   JJB   JMA   JMT   LJX   Date Received 04/03/2007 Decision Date 07/30/2007 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