CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name BECKMAN COULTER ICON MICROALB   Document Number K022538 Analyte Name Albumin, Urinary Analyte Specialty General Chemistry Complexity WAIVED Effective Date 05/13/2003 Device Classification Name indicator method, protein or albumin (urinary, non-quant.) 510(k) Number K022538 Device Name IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 Applicant DIAGNOSTIC CHEMICALS, LTD. (USA) 26371 eva st. laguna hills,  CA  92656 Contact mike berg Regulation Number 862.1645 Classification Product Code JIR   Date Received 08/01/2002 Decision Date 08/23/2002 Decision substantially equivalent (SE) Classification Advisory Committee Clinical Chemistry Review Advisory Committee Clinical Chemistry Statement/Summary/Purged Status Statement only statement statement Type Special Reviewed by Third Party No Expedited Review No