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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, carcinoembryonic antigen
510(k) Number K023893
Device Name ST AIA-PACK CEA ENZYME IMMUNOASSAY
Applicant
TOSOH MEDICS, INC.
347 OYSTER POINT BLVD.,
SUITE 201
SAN FRANCISCO,  CA  94080
Applicant Contact LOIS NAKAYAMA
Correspondent
TOSOH MEDICS, INC.
347 OYSTER POINT BLVD.,
SUITE 201
SAN FRANCISCO,  CA  94080
Correspondent Contact LOIS NAKAYAMA
Regulation Number866.6010
Classification Product Code
DHX  
Subsequent Product Code
JIS  
Date Received11/22/2002
Decision Date 12/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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