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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
Recalls CDRH Recalls
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