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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K031924
Device Name VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1
Applicant
Ortho-Clinical Diagnostics
100 Indigo Creek Dr.
Rochester,  NY  14626 -5101
Applicant Contact NEIL GREENBERG
Correspondent
Ortho-Clinical Diagnostics
100 Indigo Creek Dr.
Rochester,  NY  14626 -5101
Correspondent Contact NEIL GREENBERG
Regulation Number862.1150
Classification Product Code
JIT  
Subsequent Product Codes
JJE   LBR  
Date Received06/23/2003
Decision Date 08/07/2003
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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