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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 K911903
Device Name ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA
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 Number866.5750
Classification Product Code
DHB  
Date Received04/29/1991
Decision Date 08/12/1991
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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