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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameBiokit Sure-Vue RF  
Document NumberK910539
Parent Document NumberK910539
Analyte NameRheumatoid factor (RF)
Analyte SpecialtyGeneral Immunology
ComplexityMODERATE
Effective Date07/19/1999
Device Classification Name System, Test, Rheumatoid Factor
510(k) Number K910539
Device Name RHEUMAJET RF
Applicant
Biokit USA, Inc.
Can Male Llissa D'Amunt
Barcelona,  ES 08186
Applicant Contact IGNACIO ODRIOZOLA
Correspondent
Biokit USA, Inc.
Can Male Llissa D'Amunt
Barcelona,  ES 08186
Correspondent Contact IGNACIO ODRIOZOLA
Regulation Number866.5775
Classification Product Code
DHR  
Date Received01/28/1991
Decision Date 04/05/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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