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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 K864877
Device Name TRI-LEVEL LIGAND CONTROL
Applicant
Ciba Corning Diagnostics Corp.
333 Coney St.
East Walpole,  MA  02032
Applicant Contact SCHAEFER, PHD
Correspondent
Ciba Corning Diagnostics Corp.
333 Coney St.
East Walpole,  MA  02032
Correspondent Contact SCHAEFER, PHD
Regulation Number866.6010
Classification Product Code
DHX  
Date Received12/12/1986
Decision Date 05/21/1987
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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