FDA 510(k)

MDx-Chex 適用於BCP

K 號：K260041 · 2026-03-27

決定日期2026-03-27

產品代碼PMN

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

MDx-Chex for BCP is the device name listed in this FDA 510(k) record. The listed applicant is Streck, LLC. It received FDA 510(k) clearance on 2026-03-27 under 510(k) number K260041. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MDx-Chex for BCP?

MDx-Chex for BCP is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is Streck, LLC. The 510(k) number is K260041.

When did MDx-Chex for BCP receive FDA 510(k) clearance?

MDx-Chex for BCP received FDA 510(k) clearance on 2026-03-27, under 510(k) number K260041.

Who is the listed applicant for MDx-Chex for BCP?

The FDA 510(k) record lists Streck, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MDx-Chex for BCP?

The FDA product code for MDx-Chex for BCP is PMN.

其他以 Streck, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254167MDx-Chex用於BCY的醫療設備規範文本

相關器械（代碼：PMN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261475BIOFIRE® FILMARRAY® 熱帶熱症面板控制組Biofire Defense, LLC K260577FilmArray TF 控制面板 M527Maine Molecular Quality Controls, Inc.K254166MDx-Chex 適用於BCNStreck K254167MDx-Chex用於BCY的醫療設備規範文本Streck, LLC K251526FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc.K241289SPOTFIRE RSP 正負控制；SPOTFIRE RSP 負控制Maine Molecular Quality Controls, Inc.

官方來源

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