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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzymatic esterase--oxidase, cholesterol
510(k) Number K190490
Device Name VITROS XT Chemistry Products TRIG-CHOL Slides
Applicant
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester,  NY  14626
Applicant Contact Alexandra Chamberlain
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester,  NY  14626
Correspondent Contact Alexandra Chamberlain
Regulation Number862.1175
Classification Product Code
CHH  
Subsequent Product Code
CDT  
Date Received02/28/2019
Decision Date 03/27/2019
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
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