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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: 02/20/2002
Date Received: 05/09/2002
Decision Date: 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: 02/20/2002
Date Received: 05/09/2002
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Immunology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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