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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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