CLIA - Clinical Laboratory Improvement Amendments

510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA

New Search Back To Search Results Test System Name Acon Laboratories, On-Call Plus Blood Glucose Monitoring System   Document Number K090057 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 K090057 Device Name ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM Applicant ACON LABORATORIES CO. 4108 sorrento valley blvd. san diego,  CA  92121 Contact richard lenart Regulation Number 862.1345 Classification Product Code NBW   Subsequent Product Codes CGA   JJX   Date Received 01/08/2009 Decision Date 04/08/2009 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