CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Binax NOW Malaria Test  {With external controls}  Document Number K083744 Analyte Name Malarial Parasite Analyte Specialty Parasitology Complexity MODERATE Effective Date 11/09/2009 Device Classification Name kit, direct antigen, positive control 510(k) Number K083744 Device Name BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 Applicant BINAX, INC. 10 southgate rd. scarborough,  ME  04074 Contact anne jepson Regulation Number 862.1660 Classification Product Code MJZ   Date Received 12/16/2008 Decision Date 09/01/2009 Decision substantially equivalent (SE) Classification Advisory Committee Microbiology Review Advisory Committee Microbiology Statement/Summary/Purged Status Summary only summary summary Type Traditional Reviewed by Third Party No Expedited Review No