ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,

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 Architect He4, Architect He4 Calibrators And Architect He4 Controls, Models 2, 2p54, 2p54-01, 2p54-10 Sp54-01,.

Pre-market Notification Details

Device IDK093957
510k NumberK093957
Device Name:ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
ClassificationTest, Epithelial Ovarian Tumor Associated Antigen (he4)
Applicant FUJIREBIO DIAGNOSTICS, INC 201 GREAT VALLEY PARKWAY Malvern,  PA  19355 -1307
ContactStacey Dolan
CorrespondentStacey Dolan
FUJIREBIO DIAGNOSTICS, INC 201 GREAT VALLEY PARKWAY Malvern,  PA  19355 -1307
Product CodeOIU  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-23
Decision Date2010-03-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740138349 K093957 000
00380740048433 K093957 000
00380740003982 K093957 000
00380740003975 K093957 000

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