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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 K193313
Device Name Elecsys Anti-TSHR
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianpolis,  IN  46256
Applicant Contact Reanna Toney
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianpolis,  IN  46256
Correspondent Contact Reanna Toney
Regulation Number866.5870
Classification Product Code
JZO  
Date Received11/29/2019
Decision Date 02/27/2020
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
Recalls CDRH Recalls
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