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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Triiodothyronine
510(k) Number K991252
Device Name AIA-PACK FT3 ASSAY
Applicant
Tosoh Medics, Inc.
347 Oyster Pt. Blvd.,
Suite 201
South San Francisco,  CA  94080
Applicant Contact LOIS NAKAYAMA
Correspondent
Tosoh Medics, Inc.
347 Oyster Pt. Blvd.,
Suite 201
South San Francisco,  CA  94080
Correspondent Contact LOIS NAKAYAMA
Regulation Number862.1710
Classification Product Code
CDP  
Date Received04/13/1999
Decision Date 05/11/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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