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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 K083391
Device Name THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
Applicant
Diagnostic Hybrids, Inc.
1055 E. State St., Suite 100
Athens,  OH  45701
Applicant Contact GAIL R GOODRUM
Correspondent
Diagnostic Hybrids, Inc.
1055 E. State St., Suite 100
Athens,  OH  45701
Correspondent Contact GAIL R GOODRUM
Regulation Number866.5870
Classification Product Code
JZO  
Date Received11/17/2008
Decision Date 05/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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