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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urease, Photometric, Urea Nitrogen
510(k) Number K190326
Device Name VITROS XT Chemistry Products UREA-CREA Slides
Applicant
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626
Applicant Contact Darlene Phillips
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626
Correspondent Contact Darlene Phillips
Regulation Number862.1770
Classification Product Code
CDN  
Subsequent Product Code
JFY  
Date Received02/13/2019
Decision Date 03/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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
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