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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 K924857
Device Name AIA-PACK CEA CALIBRATION VERIFICATION TEST SET
Applicant
Tosoh Medics, Inc.
800 A Gateway Blvd.
South San Francisco,  CA  94080
Applicant Contact RICHARD M CROMPTON
Correspondent
Tosoh Medics, Inc.
800 A Gateway Blvd.
South San Francisco,  CA  94080
Correspondent Contact RICHARD M CROMPTON
Regulation Number866.6010
Classification Product Code
DHX  
Date Received09/28/1992
Decision Date 03/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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