CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name BECKMAN COULTER PRIMARY CARE DIAGNOSTICS GASTROCCULT   Document Number K821884 Analyte Name Gastric pH Analyte Specialty General Chemistry Complexity WAIVED Effective Date 08/30/2001 Device Classification Name reagent, occult blood 510(k) Number K821884 Device Name GASTROCCULT TM Applicant   SMITH KLINE DIAGNOSTICS, INC. Contact Regulation Number 864.6550 Classification Product Code KHE   Date Received 06/25/1982 Decision Date 10/08/1982 Decision substantially equivalent (SE) Classification Advisory Committee Hematology Review Advisory Committee Hematology Statement/Summary/Purged Status Purged, no summary or statement Type Traditional Reviewed by Third Party No Expedited Review