CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name PRINCETON BIOMEDITECH STATUS FIRST STREP A   Document Number K040708 Analyte Name Streptococcus, Group A Analyte Specialty Bacteriology Complexity MODERATE Effective Date 12/22/2004 Device Classification Name antigens, all groups, streptococcus spp. 510(k) Number K040708 Device Name STATUS FIRST STREP A Applicant PRINCETON BIOMEDITECH CORP. 4242 u.s. rt. 1 monmouth junction,  NJ  08852 190 Contact jemo kang Regulation Number 866.3740 Classification Product Code GTY   Date Received 04/12/2004 Decision Date 11/22/2004 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Microbiology Review Advisory Committee Microbiology Statement/Summary/Purged Status Summary only summary summary FDA Review Decision Summary Type Traditional Reviewed by Third Party No Expedited Review No