FDA 510(k)

iDart Lyme IgM ImmunoBlot Kit

K-Number: K242872 · 2025-06-12

Decision Date2025-06-12

Product CodeLSR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

iDart Lyme IgM ImmunoBlot Kit is a medical device manufactured by Id-Fish Technology, Inc.. It received FDA 510(k) clearance on 2025-06-12 under approval number K242872. 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 iDart Lyme IgM ImmunoBlot Kit?

iDart Lyme IgM ImmunoBlot Kit is a medical device that received FDA 510(k) clearance on 2025-06-12. It is manufactured by Id-Fish Technology, Inc.. The 510(k) number is K242872.

When was iDart Lyme IgM ImmunoBlot Kit approved by the FDA?

iDart Lyme IgM ImmunoBlot Kit received FDA 510(k) clearance on 2025-06-12, under approval number K242872.

What company makes iDart Lyme IgM ImmunoBlot Kit?

iDart Lyme IgM ImmunoBlot Kit is manufactured by Id-Fish Technology, Inc..

What is the FDA product code for iDart Lyme IgM ImmunoBlot Kit?

The FDA product code for iDart Lyme IgM ImmunoBlot Kit is LSR.

Other Devices by Id-Fish Technology, Inc.

DEN160025ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit K233367iDart Lyme IgG ImmunoBlot Kit

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.