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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipoprotein X, Antigen, Antiserum, Control
510(k) Number K013278
Device Name TINA-QUANT APOLIPOPROTEIN A-1 VER.2
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46256
Applicant Contact HELEN TORNEY
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46256
Correspondent Contact HELEN TORNEY
Regulation Number866.5590
Classification Product Code
DEL  
Date Received10/01/2001
Decision Date 11/15/2001
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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