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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 K152433
Device Name VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7
Applicant
Ortho Clinical Diagnostics
100 Indigo Creek Dr.
Rochester,  NY  14626
Applicant Contact Jessica Miller
Correspondent
Ortho Clinical Diagnostics
100 Indigo Creek Dr.
Rochester,  NY  14626
Correspondent Contact Jessica Miller
Regulation Number866.5270
Classification Product Code
DCK  
Subsequent Product Code
JIT  
Date Received08/27/2015
Decision Date 09/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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