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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 K001310
Device Name VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Applicant Contact MARLENE A SHULMAN
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Correspondent Contact MARLENE A SHULMAN
Regulation Number862.1225
Classification Product Code
JFY  
Subsequent Product Code
JIX  
Date Received04/25/2000
Decision Date 05/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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