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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, Thyroid Autoantibody
510(k) Number K981559
Device Name UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY
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 Number866.5870
Classification Product Code
JZO  
Date Received05/01/1998
Decision Date 07/07/1998
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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