FDA 510(k)

MDx-Chex用於BCID2

K 號：K212576 · 2022-01-19

決定日期2022-01-19

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 BCID2 is the device name listed in this FDA 510(k) record. The listed applicant is Streck, Inc.. It received FDA 510(k) clearance on 2022-01-19 under 510(k) number K212576. 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 BCID2?

MDx-Chex for BCID2 is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Streck, Inc.. The 510(k) number is K212576.

When did MDx-Chex for BCID2 receive FDA 510(k) clearance?

MDx-Chex for BCID2 received FDA 510(k) clearance on 2022-01-19, under 510(k) number K212576.

Who is the listed applicant for MDx-Chex for BCID2?

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

What is the FDA product code for MDx-Chex for BCID2?

The FDA product code for MDx-Chex for BCID2 is PMN.

其他以 Streck, Inc. 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。

K231776無細胞DNA BCT

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.K260041MDx-Chex 適用於BCPStreck, LLC 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.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。