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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Haptoglobin, Antigen, Antiserum, Control
510(k) Number K972639
Device Name TINA-QUANT HAPTOGLOBIN
Applicant
Boehringer Mannheim Corp.
2380a Bisso Ln.
Concord,  CA  94520
Applicant Contact MARY KONING
Correspondent
Boehringer Mannheim Corp.
2380a Bisso Ln.
Concord,  CA  94520
Correspondent Contact MARY KONING
Regulation Number866.5460
Classification Product Code
DAD  
Date Received07/15/1997
Decision Date 01/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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