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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transferrin, antigen, antiserum, control
510(k) Number K042477
Device Name VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Applicant Contact Darlene J Phillips
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Correspondent Contact Darlene J Phillips
Regulation Number866.5880
Classification Product Code
DDG  
Subsequent Product Codes
JIT   JJX  
Date Received09/13/2004
Decision Date 11/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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