CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Nova Stat Profile Ultra I   Document Number K960120 Analyte Name Blood Gases Analyte Specialty General Chemistry Complexity MODERATE Effective Date 04/12/1996 Device Classification Name electrode, ion specific, calcium 510(k) Number K960120 Device Name STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS Applicant NOVA BIOMEDICAL CORP. 200 prospect st. waltham,  MA  02454 914 Contact paul w macdonald Regulation Number 862.1145 Classification Product Code JFP   Subsequent Product Codes CDS   CFA   CHL   JJS   Date Received 01/11/1996 Decision Date 03/11/1996 Decision substantially equivalent (SE) Classification Advisory Committee Clinical Chemistry Review Advisory Committee Clinical Chemistry Statement/Summary/Purged Status Statement/purged 510(k) Type Traditional Reviewed by Third Party No Expedited Review No