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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 K041863
Device Name VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Applicant Contact MARLENE A HANNA
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Correspondent Contact MARLENE A HANNA
Regulation Number866.5775
Classification Product Code
DHR  
Date Received07/09/2004
Decision Date 09/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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