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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ldl & Vldl Precipitation, Hdl
510(k) Number K984303
Device Name VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
Applicant
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626
Applicant Contact MARLENE SHULMAN
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626
Correspondent Contact MARLENE SHULMAN
Regulation Number862.1475
Classification Product Code
LBR  
Subsequent Product Code
JIS  
Date Received12/02/1998
Decision Date 01/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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