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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, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
510(k) Number K020566
Device Name FUJIREBIO DIAGNOSTICS CA 19-9 RIA
Applicant
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.
Malvern,  PA  19355
Applicant Contact DANIEL J O'SHANNESSY
Correspondent
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.
Malvern,  PA  19355
Correspondent Contact DANIEL J O'SHANNESSY
Regulation Number866.6010
Classification Product Code
NIG  
Date Received02/20/2002
Decision Date 05/09/2002
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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