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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometric, Cortisol
510(k) Number K954591
Device Name AIA-PACK CORT ASSAY
Applicant
Tosoh Medics, Inc.
373 D Vintage Park Dr.
Foster City,  CA  94404
Applicant Contact LORI ROBINSON
Correspondent
Tosoh Medics, Inc.
373 D Vintage Park Dr.
Foster City,  CA  94404
Correspondent Contact LORI ROBINSON
Regulation Number862.1205
Classification Product Code
JFT  
Date Received10/02/1995
Decision Date 12/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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