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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, Immunological, Antigen, Tumor
510(k) Number K963803
Device Name CENTOCOR CA 15-3 RIA MODEL NO. 800-033
Applicant
Centocor, Inc.
200 Great Valley Pkwy.
Malvern,  PA  19355 -1307
Applicant Contact CHRISTOPHER ZALESKY
Correspondent
Centocor, Inc.
200 Great Valley Pkwy.
Malvern,  PA  19355 -1307
Correspondent Contact CHRISTOPHER ZALESKY
Regulation Number866.6010
Classification Product Code
MOI  
Date Received09/23/1996
Decision Date 05/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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