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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1-Lipoprotein, Antigen, Antiserum, Control
510(k) Number K013249
Device Name TINA-QUANT APOLIPOPROTEIN VER.2
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46256
Applicant Contact HELEN T TORNEY
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46256
Correspondent Contact HELEN T TORNEY
Regulation Number866.5580
Classification Product Code
DER  
Date Received09/28/2001
Decision Date 11/16/2001
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
Recalls CDRH Recalls
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