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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 K983992
Device Name NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY
Applicant
Nichols Institute Diagnostics
33051 Calle Aviador
San Juan Capistrano,  CA  92675
Applicant Contact JIMMY WONG
Correspondent
Nichols Institute Diagnostics
33051 Calle Aviador
San Juan Capistrano,  CA  92675
Correspondent Contact JIMMY WONG
Regulation Number866.5870
Classification Product Code
JZO  
Date Received11/09/1998
Decision Date 01/26/1999
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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