Anti-Borrelia Burgdorferi US EUROLINE-WB (IgM)

Reagent, Borrelia Serological Reagent

EUROIMMUN US, Inc.

The following data is part of a premarket notification filed by Euroimmun Us, Inc. with the FDA for Anti-borrelia Burgdorferi Us Euroline-wb (igm).

Pre-market Notification Details

Device IDK172722
510k NumberK172722
Device Name:Anti-Borrelia Burgdorferi US EUROLINE-WB (IgM)
ClassificationReagent, Borrelia Serological Reagent
Applicant EUROIMMUN US, Inc. 1 Bloomfield Ave. Mountain Lakes,  NJ  07046
ContactMichael A. Locke
CorrespondentMichael A. Locke
EUROIMMUN US, Inc. 1 Bloomfield Ave. Mountain Lakes,  NJ  07046
Product CodeLSR  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-11
Decision Date2017-12-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049016134992 K172722 000
04049016134985 K172722 000

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