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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, low density, lipoprotein
510(k) Number K041720
Device Name VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Applicant Contact MARLENE A HANNA
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14626 -5101
Correspondent Contact MARLENE A HANNA
Regulation Number862.1475
Classification Product Code
MRR  
Subsequent Product Codes
JIT   JJX  
Date Received06/24/2004
Decision Date 08/25/2004
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
Recalls CDRH Recalls
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