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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 K092229
Device Name THYRETAIN TM TSI REPORTER BIOASSAY
Applicant
Diagnostic Hybrids, Inc.
1055 E. State St., Suite 100
Athens,  OH  45701
Applicant Contact Ronald H Lollar
Correspondent
Diagnostic Hybrids, Inc.
1055 E. State St., Suite 100
Athens,  OH  45701
Correspondent Contact Ronald H Lollar
Regulation Number866.5870
Classification Product Code
JZO  
Date Received07/23/2009
Decision Date 05/18/2010
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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