CYFRA 21-1 EIA MODEL 211-10

Cytokeratin Fragments 21-1 Eia Kit

FUJIREBIO DIAGNOSTICS, INC

The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc with the FDA for Cyfra 21-1 Eia Model 211-10.

Pre-market Notification Details

Device IDK100831
510k NumberK100831
Device Name:CYFRA 21-1 EIA MODEL 211-10
ClassificationCytokeratin Fragments 21-1 Eia Kit
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 CodeOVK  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-24
Decision Date2011-05-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17350066140135 K100831 000

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