EUROIMMUN ANTI-M2-3E ELISA (IGG)

Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

EUROIMMUN US INC

The following data is part of a premarket notification filed by Euroimmun Us Inc with the FDA for Euroimmun Anti-m2-3e Elisa (igg).

Pre-market Notification Details

Device IDK092736
510k NumberK092736
Device Name:EUROIMMUN ANTI-M2-3E ELISA (IGG)
ClassificationAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant EUROIMMUN US INC 95 WASHINGTON ST Morristown,  NJ  07960
ContactKathryn Kohl
CorrespondentKathryn Kohl
EUROIMMUN US INC 95 WASHINGTON ST Morristown,  NJ  07960
Product CodeDBM  
CFR Regulation Number866.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-04
Decision Date2010-09-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049016027157 K092736 000

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