Transferrin

Transferrin, Antigen, Antiserum, Control

BioSystems S.A.

The following data is part of a premarket notification filed by Biosystems S.a. with the FDA for Transferrin.

Pre-market Notification Details

Device IDK190495
510k NumberK190495
Device Name:Transferrin
ClassificationTransferrin, Antigen, Antiserum, Control
Applicant BioSystems S.A. Costa Brava, 30 Barcelona,  ES 08030
ContactNoelia Gil
CorrespondentNoelia Gil
BioSystems S.A. Costa Brava, 30 Barcelona,  ES 08030
Product CodeDDG  
CFR Regulation Number866.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyImmunology
510k Review PanelImmunology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-28
Decision Date2020-03-16

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