VITROS CA 19-9

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 Vitros Ca 19-9.

Pre-market Notification Details

Device IDK052889
510k NumberK052889
Device Name:VITROS CA 19-9
ClassificationSystem, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer
Applicant FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern,  PA  19355
ContactDiana L Wolaniuk
CorrespondentDiana L Wolaniuk
FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern,  PA  19355
Product CodeNIG  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-13
Decision Date2005-12-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750002368 K052889 000

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