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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameBeckman Coulter AU5400 Chemistry Analyzer  
Document NumberK981743
Parent Document NumberK952425
Analyte NameApolipoprotein A1
Analyte SpecialtyGeneral Chemistry
ComplexityMODERATE
Effective Date10/04/2011
Device Classification Name Turbidimetric Method, Lipoproteins
510(k) Number K952425
Device Name OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT
Applicant
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747
Correspondent Contact LAURA STORMS-TYLER
Regulation Number862.1475
Classification Product Code
JHN  
Date Received05/24/1995
Decision Date 07/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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