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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
Recalls CDRH Recalls
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