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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Creatinine
510(k) Number K063591
Device Name VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DRIVE
MC881
ROCHESTER,  NY  14626 -5101
Applicant Contact MICHAEL M BYRNE
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DRIVE
MC881
ROCHESTER,  NY  14626 -5101
Correspondent Contact MICHAEL M BYRNE
Regulation Number862.1225
Classification Product Code
JFY  
Subsequent Product Code
JIX  
Date Received12/01/2006
Decision Date 12/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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