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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 K962976
Device Name PHARMACIA CAP SYSTEM RAST FEIA
Applicant
Pharmacia & Upjohn Co.
3 Bethesda Metro Center
Suite 750
Bethesda,  MD  20814
Applicant Contact JOYCE DAVIS
Correspondent
Pharmacia & Upjohn Co.
3 Bethesda Metro Center
Suite 750
Bethesda,  MD  20814
Correspondent Contact JOYCE DAVIS
Regulation Number866.5750
Classification Product Code
DHB  
Date Received07/31/1996
Decision Date 12/23/1996
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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