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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 K981522
Device Name AIA-PACK TGAB ASSAY
Applicant
TOSOH MEDICS, INC.
373 VINTAGE PARK DR.
SUITE D
FOSTER CITY,  CA  94404
Applicant Contact LORI ROBINSON
Correspondent
TOSOH MEDICS, INC.
373 VINTAGE PARK DR.
SUITE D
FOSTER CITY,  CA  94404
Correspondent Contact LORI ROBINSON
Regulation Number866.5870
Classification Product Code
JZO  
Date Received04/28/1998
Decision Date 10/08/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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