FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL

Test, Epithelial Ovarian Tumor Associated Antigen (he4)

FUJIREBIO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Fujirebio Diagnostics Tumor Marker Control.

Pre-market Notification Details

Device IDK103676
510k NumberK103676
Device Name:FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
ClassificationTest, Epithelial Ovarian Tumor Associated Antigen (he4)
Applicant FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern,  PA  19355 -1307
ContactDiana Lyn Dickson
CorrespondentDiana Lyn Dickson
FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern,  PA  19355 -1307
Product CodeOIU  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-16
Decision Date2011-07-19
Summary:summary

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