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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipoprotein, Low-Density, Antigen, Antiserum, Control
510(k) Number K013207
Device Name TINA-QUANT APOLIPOPROTEIN B VER.2
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Indianpolis,  IN  46256
Applicant Contact KAY A TAYLOR
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianpolis,  IN  46256
Correspondent Contact KAY A TAYLOR
Regulation Number866.5600
Classification Product Code
DFC  
Date Received09/25/2001
Decision Date 11/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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