CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name DIATECH DIAGNOSTICS URISCREEN  (For OTC use) Document Number K981084 Analyte Name Catalase, Urine Analyte Specialty Bacteriology Complexity WAIVED Effective Date 02/04/1999 Device Classification Name kit, screening, urine 510(k) Number K981084 Device Name URISCREEN Applicant DIATECH DIAGNOSTICS,INC. 15 oak st. beverly farms,  MA  01915 Contact fran white Regulation Number 866.2660 Classification Product Code JXA   Date Received 03/25/1998 Decision Date 10/07/1998 Decision substantially equivalent (SE) Classification Advisory Committee Microbiology Review Advisory Committee Microbiology Statement/Summary/Purged Status Summary/purged 510(k) summary summary Type Traditional Reviewed by Third Party No Expedited Review No