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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K041799
Device Name VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS
Applicant
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626 -5101
Applicant Contact CAREY MAYO
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626 -5101
Correspondent Contact CAREY MAYO
Regulation Number866.5270
Classification Product Code
NQD  
Subsequent Product Codes
JIT   JJX  
Date Received07/02/2004
Decision Date 08/25/2004
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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