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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme immunoassay, non-radiolabeled, total thyroxine
510(k) Number K160495
Device Name VITROS® Automation Solutions
Applicant
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive MC00881
Rochester,  NY  14626
Applicant Contact Darlene J Phillips
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive MC00881
Rochester,  NY  14626
Correspondent Contact Darlene J Phillips
Regulation Number862.1700
Classification Product Code
KLI  
Subsequent Product Codes
JJE   KLT   LCD  
Date Received02/22/2016
Decision Date 10/18/2016
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
Recalls CDRH Recalls
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