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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 AU2700 Chemistry Analyzer  
Document NumberK981743
Parent Document NumberK924659
Analyte NameProtein, total
Analyte SpecialtyGeneral Chemistry
ComplexityMODERATE
Effective Date10/04/2011
Device Classification Name Biuret (Colorimetric), Total Protein
510(k) Number K924659
Device Name OLYUMPUS TOTAL PROTEIN REAGENT
Applicant
Olympus Corp.
4 Nevada Dr.
Lake Success,  NY  11042
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus Corp.
4 Nevada Dr.
Lake Success,  NY  11042
Correspondent Contact LAURA STORMS-TYLER
Regulation Number862.1635
Classification Product Code
CEK  
Date Received09/15/1992
Decision Date 12/29/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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