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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, Thyroglobulin
510(k) Number K221890
Device Name Elecsys Tg II
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  42650
Applicant Contact Edie Eads
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolos,  IN  46250
Correspondent Contact Phil Williams
Regulation Number866.6010
Classification Product Code
MSW  
Subsequent Product Codes
JIT   JJX   JJY  
Date Received06/29/2022
Decision Date 09/30/2023
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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