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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K972586
Device Name AIA-PACK TSH 3RD-GEN 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 Number862.1690
Classification Product Code
JLW  
Subsequent Product Code
JIS  
Date Received07/11/1997
Decision Date 08/29/1997
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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