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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Immunological, Antigen, Tumor
510(k) Number K965141
Device Name TRUQUANT BR RIA
Applicant
Biomira USA, Inc.
1002 E. Park Blvd.
Cranberry,  NJ  08512
Applicant Contact JILLIAN CASTRUCCI
Correspondent
Biomira USA, Inc.
1002 E. Park Blvd.
Cranberry,  NJ  08512
Correspondent Contact JILLIAN CASTRUCCI
Regulation Number866.6010
Classification Product Code
MOI  
Date Received12/23/1996
Decision Date 10/31/1997
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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