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FDA 510(k)

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)

K-Number: K172722 · 2017-12-10

ApplicantEuroimmun Us, Inc.
Decision Date2017-12-10
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) is a medical device manufactured by Euroimmun Us, Inc.. It received FDA 510(k) clearance on 2017-12-10 under approval number K172722. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)?

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) is a medical device that received FDA 510(k) clearance on 2017-12-10. It is manufactured by Euroimmun Us, Inc.. The 510(k) number is K172722.

When was Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) approved by the FDA?

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) received FDA 510(k) clearance on 2017-12-10, under approval number K172722.

What company makes Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)?

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) is manufactured by Euroimmun Us, Inc..

What is the FDA product code for Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)?

The FDA product code for Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) is LSR.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED

Other Devices by Euroimmun Us, Inc.

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Related Devices (Code: LSR)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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