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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Antigen, Antiserum, Control
510(k) Number K964152
Device Name UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
Applicant
Pharmacia, Inc.
5094 St. Andrews Dr.
Westervillle,  OH  43082
Applicant Contact KAREN E MATIS
Correspondent
Pharmacia, Inc.
5094 St. Andrews Dr.
Westervillle,  OH  43082
Correspondent Contact KAREN E MATIS
Regulation Number866.5510
Classification Product Code
DGC  
Date Received10/16/1996
Decision Date 04/23/1997
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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