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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 K915133
Device Name SYNELISA TMAB
Applicant
Elias U.S.A., Inc.
373 280th St.
Osceola,  WI  54020
Correspondent
Elias U.S.A., Inc.
373 280th St.
Osceola,  WI  54020
Regulation Number866.5870
Classification Product Code
JZO  
Date Received11/13/1991
Decision Date 04/08/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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