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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinary Homocystine (Nonquantitative) Test System
510(k) Number K061588
Device Name VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS
Applicant
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626 -5101
Applicant Contact MICHAEL BYRNE
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626 -5101
Correspondent Contact MICHAEL BYRNE
Regulation Number862.1377
Classification Product Code
LPS  
Subsequent Product Codes
JIT   JJX  
Date Received06/08/2006
Decision Date 07/21/2006
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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