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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 K980855
Device Name IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT
Applicant
Dpc Cirrus
B13-B18, 111 Canfield Ave.
Randolph,  NJ  07869
Applicant Contact ROBERT M DI TULLIO
Correspondent
Dpc Cirrus
B13-B18, 111 Canfield Ave.
Randolph,  NJ  07869
Correspondent Contact ROBERT M DI TULLIO
Regulation Number866.6010
Classification Product Code
DHX  
Date Received03/05/1998
Decision Date 04/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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