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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 AU640 Chemistry Analyzer  
Document NumberK981743
Parent Document NumberK070453
Analyte NameD-dimer
Analyte SpecialtyHematology
ComplexityMODERATE
Effective Date10/04/2011
Device Classification Name Fibrin Split Products
510(k) Number K070453
Device Name OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
Applicant
Olympus Life & Material Science Europa GmbH (Irish
3131 W. Royal Ln.
Irving,  TX  75063
Applicant Contact STEPHANIE G SCHWARTZ
Correspondent
Olympus Life & Material Science Europa GmbH (Irish
3131 W. Royal Ln.
Irving,  TX  75063
Correspondent Contact STEPHANIE G SCHWARTZ
Regulation Number864.7320
Classification Product Code
GHH  
Date Received02/16/2007
Decision Date 06/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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