FDA 510(k)

Anti-Borrelia burgdorferi US Westernblot (IgG)

K-Number: K161513 · 2016-08-25

Decision Date2016-08-25

Product CodeLSR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Anti-Borrelia burgdorferi US Westernblot (IgG) is a medical device manufactured by Euroimmun US. It received FDA 510(k) clearance on 2016-08-25 under approval number K161513. 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 Westernblot (IgG)?

Anti-Borrelia burgdorferi US Westernblot (IgG) is a medical device that received FDA 510(k) clearance on 2016-08-25. It is manufactured by Euroimmun US. The 510(k) number is K161513.

When was Anti-Borrelia burgdorferi US Westernblot (IgG) approved by the FDA?

Anti-Borrelia burgdorferi US Westernblot (IgG) received FDA 510(k) clearance on 2016-08-25, under approval number K161513.

What company makes Anti-Borrelia burgdorferi US Westernblot (IgG)?

Anti-Borrelia burgdorferi US Westernblot (IgG) is manufactured by Euroimmun US.

What is the FDA product code for Anti-Borrelia burgdorferi US Westernblot (IgG)?

The FDA product code for Anti-Borrelia burgdorferi US Westernblot (IgG) is LSR.

Related Clinical Trials

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Related Devices (Code: LSR)

K172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)Euroimmun Us, Inc. K172254Lyme B. burgdorferi (IgM) MarStripe TestTrinity Biotech K163713Sofia Lyme FIA, Sofia Lyme Control SetQuidel Corporation K163695Borrelia B31 ViraChip IgM Test KitViramed Biotech AG K163504Borrelia B31 ViraChip IgG Test KitViramed Biotech AG K163095Lyme B. burgdorferi (IgG) MarStripe TestTrinity Biotech

Official Source

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