OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.

System, Test, Rheumatoid Factor

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Rf Latex Calibrator, And Olympus Rf Latex Reagent With Model(s): Odc0028, And Osr61105..

Pre-market Notification Details

Device IDK060201
510k NumberK060201
Device Name:OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.
ClassificationSystem, Test, Rheumatoid Factor
Applicant OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving,  TX  75063 -3104
ContactBev Harding
CorrespondentBev Harding
OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving,  TX  75063 -3104
Product CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-26
Decision Date2006-06-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590070571 K060201 000
15099590010966 K060201 000

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