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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
510(k) Number K993109
Device Name VARELISA RECOMBI ANA PROFILE
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 Number866.5100
Classification Product Code
LJM  
Date Received09/17/1999
Decision Date 11/12/1999
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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