FIDIS CELIAC

Antibodies, Gliadin

BIOMEDICAL DIAGNOSTICS (BMD) SA

The following data is part of a premarket notification filed by Biomedical Diagnostics (bmd) Sa with the FDA for Fidis Celiac.

Pre-market Notification Details

Device IDK053383
510k NumberK053383
Device Name:FIDIS CELIAC
ClassificationAntibodies, Gliadin
Applicant BIOMEDICAL DIAGNOSTICS (BMD) SA ACTIPOLE 25 4-6 BLD DE BEAUBOURG Marne La Vallee Cedex 2,  FR 77435
ContactCourivaud Christelle
CorrespondentCourivaud Christelle
BIOMEDICAL DIAGNOSTICS (BMD) SA ACTIPOLE 25 4-6 BLD DE BEAUBOURG Marne La Vallee Cedex 2,  FR 77435
Product CodeMST  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-05
Decision Date2006-03-29
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.