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FDA 510(k) Application Details - K191973
Device Classification Name
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
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510(K) Number
K191973
Device Name
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Applicant
Fujirebio Dianostics, Inc.
201 Great Valley Parkway
Malvern, PA 19355 US
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Contact
Kristin Maddaloni
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Regulation Number
866.6010
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Classification Product Code
NIG
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More FDA Info for this Product Code
Date Received
07/24/2019
Decision Date
10/22/2019
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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