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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K161140
Device Name VITROS Chemistry Products Calibrator Kit 3
Applicant
ORTHO-CLINICAL DIAGNOSTICS, INC.
100 INDIGO CREEK DRIVE
ROCHESTER,  NY  14626 -5101
Applicant Contact MARLENE HANNA
Correspondent
ORTHO-CLINICAL DIAGNOSTICS, INC.
100 INDIGO CREEK DRIVE
ROCHESTER,  NY  14626 -5101
Correspondent Contact MARLENE HANNA
Regulation Number862.1150
Classification Product Code
JIX  
Date Received04/22/2016
Decision Date 05/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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