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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 K981521
Device Name AIA-PACK TPOAB ASSAY
Applicant
Tosoh Medics, Inc.
373 Vintage Park Dr.
Suite D
Foster City,  CA  94404
Applicant Contact LON ROBINSON
Correspondent
Tosoh Medics, Inc.
373 Vintage Park Dr.
Suite D
Foster City,  CA  94404
Correspondent Contact LON 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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