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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Rheumatoid Factor
510(k) Number K060201
Device Name OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.
Applicant
Olympus America, Inc.
3131 W. Royal Ln.
Irving,  TX  75063 -3104
Applicant Contact BEV HARDING
Correspondent
Olympus America, Inc.
3131 W. Royal Ln.
Irving,  TX  75063 -3104
Correspondent Contact BEV HARDING
Regulation Number866.5775
Classification Product Code
DHR  
Subsequent Product Code
JIT  
Date Received01/26/2006
Decision Date 06/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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