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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 K052000
Device Name ARCHITECT CA 19-9XR ASSAY
Applicant
FUJIREBIO DIAGNOSTICS, INC.
201 GREAT VALLEY PKWY.
MALVERN,  PA  19355 -1307
Applicant Contact DIANA L WOLANIUK
Correspondent
FUJIREBIO DIAGNOSTICS, INC.
201 GREAT VALLEY PKWY.
MALVERN,  PA  19355 -1307
Correspondent Contact DIANA L WOLANIUK
Regulation Number866.6010
Classification Product Code
NIG  
Subsequent Product Codes
JIT   JJX  
Date Received07/25/2005
Decision Date 10/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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