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FDA 510(k), K020566, FUJIREBIO DIAGNOSTICS CA 19-9 RIA
FDA 510(k), K020566, FUJIREBIO DIAGNOSTICS CA 19-9 RIA
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510(K) Number: K020566
Device Name: FUJIREBIO DIAGNOSTICS CA 19-9 RIA
Manufacturer: DANIEL J O'SHANNESSY
Device Classification Name: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Regulation Number: NIG
Classification Product Code: KXA
Date Received: 02/20/2002
Decision Date: 05/09/2002
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Immunology
Device Name: FUJIREBIO DIAGNOSTICS CA 19-9 RIA
Manufacturer: DANIEL J O'SHANNESSY
Device Classification Name: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Regulation Number: NIG
Classification Product Code: KXA
Date Received: 02/20/2002
Decision Date: 05/09/2002
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Immunology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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