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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 K911631
Device Name PHARMACIA SPECIFIC IGE CONTROL
Applicant
Pharmacia, Inc.
P.O. Box 10087
New Brunswick,  NJ  08906
Applicant Contact ALBERT P MAYO
Correspondent
Pharmacia, Inc.
P.O. Box 10087
New Brunswick,  NJ  08906
Correspondent Contact ALBERT P MAYO
Regulation Number866.5510
Classification Product Code
DGC  
Date Received04/11/1991
Decision Date 04/24/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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