CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name ESA Biosciences LeadCare II Blood Lead Testing System  (Whole Blood) Document Number K052549 Analyte Name Blood Lead Analyte Specialty Toxicology / TDM Complexity WAIVED Effective Date 09/18/2006 Device Classification Name lead, atomic absorption 510(k) Number K052549 Device Name LEADCARE II BLOOD LEAD TESTING SYSTEM Applicant ESA BIOSCIENCES INC. 22 alpha rd. chelmsford,  MA  01824 417 Contact harold asp Regulation Number 862.3550 Classification Product Code DOF   Date Received 09/16/2005 Decision Date 10/06/2005 Decision substantially equivalent (SE) Classification Advisory Committee Toxicology 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