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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, Radioallergosorbent (Rast) Immunological
510(k) Number K982343
Device Name ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3
Applicant
Pharmacia & Upjohn Co.
5094 St. Andrews Dr.
Westervillle,  OH  43082
Applicant Contact KAREN E MATIS
Correspondent
Pharmacia & Upjohn Co.
5094 St. Andrews Dr.
Westervillle,  OH  43082
Correspondent Contact KAREN E MATIS
Regulation Number866.5750
Classification Product Code
DHB  
Date Received07/06/1998
Decision Date 09/15/1998
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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