CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Stanbio HemoPoint H2 DM Hemoglobin Measurement System  {with Data Management}  Document Number K090093 Analyte Name Hemoglobin Analyte Specialty Hematology Complexity WAIVED Effective Date 06/12/2009 Device Classification Name system, hemoglobin, automated 510(k) Number K090093 Device Name STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM Applicant STANBIO LABORATORY 1261 north main st. boerne,  TX  78006 Contact kirk johnson Regulation Number 864.5620 Classification Product Code GKR   Date Received 01/14/2009 Decision Date 06/10/2009 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Hematology Review Advisory Committee Hematology Statement/Summary/Purged Status Summary only summary summary FDA Review Decision Summary Type Special Reviewed by Third Party No Expedited Review No