FUJIREBIO DIAGNOSTICS CA 19-9 RIA

System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer

FUJIREBIO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Fujirebio Diagnostics Ca 19-9 Ria.

Pre-market Notification Details

Device IDK020566
510k NumberK020566
Device Name:FUJIREBIO DIAGNOSTICS CA 19-9 RIA
ClassificationSystem, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer
Applicant FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern,  PA  19355 -1307
ContactDaniel J O'shannessy
CorrespondentDaniel J O'shannessy
FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern,  PA  19355 -1307
Product CodeNIG  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-20
Decision Date2002-05-09
Summary:summary

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