FDA 510(k) Application Details - K020566

Device Classification Name System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

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510(K) Number K020566
Device Name System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Applicant FUJIREBIO DIAGNOSTICS, INC.
201 GREAT VALLEY PKWY.
MALVERN, PA 19355-1307 US
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Contact DANIEL J O'SHANNESSY
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Regulation Number 866.6010

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Classification Product Code NIG
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Date Received 02/20/2002
Decision Date 05/09/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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