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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameRandox Laboratories RF Latex Test  
Document NumberK961169
Parent Document NumberK961169
Analyte NameRheumatoid factor (RF)
Analyte SpecialtyGeneral Immunology
ComplexityMODERATE
Effective Date07/26/1996
Device Classification Name System, Test, Rheumatoid Factor
510(k) Number K961169
Device Name RHEUMATOID FACTOR LATEX SLIDE TEST KIT
Applicant
Randox Laboratories, Ltd.
Ardmore, Diamond Rd.
Crumlin,  IE BT29 4QY
Applicant Contact P. ARMSTRONG
Correspondent
Randox Laboratories, Ltd.
Ardmore, Diamond Rd.
Crumlin,  IE BT29 4QY
Correspondent Contact P. ARMSTRONG
Regulation Number866.5775
Classification Product Code
DHR  
Date Received03/25/1996
Decision Date 06/26/1996
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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