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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name c-reactive protein, antigen, antiserum, and control
510(k) Number K030626
Device Name VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
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 Number866.5270
Classification Product Code
DCK  
Subsequent Product Code
JIT  
Date Received02/27/2003
Decision Date 03/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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