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FDA 510(k)

iDart Lyme IgG ImmunoBlot Kit

K-Number: K233367 · 2024-08-12

ApplicantId-Fish Technology, Inc.
Decision Date2024-08-12
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

iDart Lyme IgG ImmunoBlot Kit is the device name listed in this FDA 510(k) record. The listed applicant is Id-Fish Technology, Inc.. It received FDA 510(k) clearance on 2024-08-12 under 510(k) number K233367. 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 IgG ImmunoBlot Kit?

iDart Lyme IgG ImmunoBlot Kit is a medical device that received FDA 510(k) clearance on 2024-08-12. The listed applicant is Id-Fish Technology, Inc.. The 510(k) number is K233367.

When did iDart Lyme IgG ImmunoBlot Kit receive FDA 510(k) clearance?

iDart Lyme IgG ImmunoBlot Kit received FDA 510(k) clearance on 2024-08-12, under 510(k) number K233367.

Who is the listed applicant for iDart Lyme IgG ImmunoBlot Kit?

The FDA 510(k) record lists Id-Fish Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Id-Fish Technology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242872iDart Lyme IgM ImmunoBlot Kit

Related Devices (Code: LSR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254295Sofia Lyme FIA; Sofia 2 Campylobacter FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)K252627Lyme-ID IgG Test; Bio-ID800Inanovate, Inc.K242872iDart Lyme IgM ImmunoBlot KitId-Fish Technology, Inc.K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control KitZeus ScientificK220016Viramed Borrela All-In-One ViraChip Test KitViramed Biotech AGK203296Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitGold Standard Diagnostics

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.

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