FDA 510(k)

iDart ライム IgM イミュノブロットキット

K番号: K242872 · 2025-06-12

決定日2025-06-12

製品コードLSR

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- MI --- URLや識別子などは原文のままです。

決定大幅同等

医療機器の概要

iDart Lyme IgM 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 2025-06-12 under 510(k) number K242872. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

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. The listed applicant is Id-Fish Technology, Inc.. The 510(k) number is K242872.

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

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

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

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

申請者としてId-Fish Technology, Inc.を記載するその他の記録

K233367iDartリュークイグG免疫バッファーキット

公式ソース

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