FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS

Extractable Antinuclear Antibody, Antigen And Control

BIOMEDICAL DIAGNOSTICS (BMD) SA

The following data is part of a premarket notification filed by Biomedical Diagnostics (bmd) Sa with the FDA for Fidistm Connective 10, Fidistm Analyzer, Caris.

Pre-market Notification Details

Device IDK102607
510k NumberK102607
Device Name:FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS
ClassificationExtractable Antinuclear Antibody, Antigen And Control
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 CodeLLL  
Subsequent Product CodeLJM
Subsequent Product CodeLKJ
Subsequent Product CodeLKO
Subsequent Product CodeLKP
Subsequent Product CodeLSW
Subsequent Product CodeMQA
Subsequent Product CodeNSU
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-10
Decision Date2010-12-03
Summary:summary

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