CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name SA SCIENTIFIC SAS STREP ALERT   Document Number K023270 Analyte Name Streptococcus, Group A Analyte Specialty Bacteriology Complexity MODERATE Effective Date 10/21/2002 Device Classification Name antigens, all groups, streptococcus spp. 510(k) Number K023270 Device Name SAS STREPALERT Applicant SA SCIENTIFIC, INC. 4919 golden quail san antonio,  TX  78240 Contact ricardo r martinez Regulation Number 866.3740 Classification Product Code GTY   Date Received 10/01/2002 Decision Date 10/17/2002 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Microbiology Review Advisory Committee Microbiology Statement/Summary/Purged Status Statement only statement statement Type Traditional Reviewed by Third Party No Expedited Review No