FDA 510(k)

Lyme B. burgdorferi (IgG) MarStripe Test

K-Number: K163095 · 2017-02-01

Decision Date2017-02-01

Product CodeLSR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Lyme B. burgdorferi (IgG) MarStripe Test is a medical device manufactured by Trinity Biotech. It received FDA 510(k) clearance on 2017-02-01 under approval number K163095. 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 Lyme B. burgdorferi (IgG) MarStripe Test?

Lyme B. burgdorferi (IgG) MarStripe Test is a medical device that received FDA 510(k) clearance on 2017-02-01. It is manufactured by Trinity Biotech. The 510(k) number is K163095.

When was Lyme B. burgdorferi (IgG) MarStripe Test approved by the FDA?

Lyme B. burgdorferi (IgG) MarStripe Test received FDA 510(k) clearance on 2017-02-01, under approval number K163095.

What company makes Lyme B. burgdorferi (IgG) MarStripe Test?

Lyme B. burgdorferi (IgG) MarStripe Test is manufactured by Trinity Biotech.

What is the FDA product code for Lyme B. burgdorferi (IgG) MarStripe Test?

The FDA product code for Lyme B. burgdorferi (IgG) MarStripe Test is LSR.

Other Devices by Trinity Biotech

K172254Lyme B. burgdorferi (IgM) MarStripe Test

Related Devices (Code: LSR)

K161513Anti-Borrelia burgdorferi US Westernblot (IgG)Euroimmun US 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

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.