FDA 510(k)

SPOTFIRE RSP 正向控制，SPOTFIRE RSP 負向控制

K 號：K221253 · 2023-02-03

申請人Maine Molecular Quality Controls, Inc.

決定日期2023-02-03

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

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control is the device name listed in this FDA 510(k) record. The listed applicant is Maine Molecular Quality Controls, Inc.. It received FDA 510(k) clearance on 2023-02-03 under 510(k) number K221253. 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 SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control?

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control is a medical device that received FDA 510(k) clearance on 2023-02-03. The listed applicant is Maine Molecular Quality Controls, Inc.. The 510(k) number is K221253.

When did SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control receive FDA 510(k) clearance?

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control received FDA 510(k) clearance on 2023-02-03, under 510(k) number K221253.

Who is the listed applicant for SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control?

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

What is the FDA product code for SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control?

The FDA product code for SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control is PMN.

其他以 Maine Molecular Quality Controls, 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。

K260577FilmArray TF 控制面板 M527 K251526FilmArray GI Control Panel M238 K241289SPOTFIRE RSP 正負控制；SPOTFIRE RSP 負控制 K233611SPOTFIRE RSP 正負控制 (M425)，SPOTFIRE RSP 阳性控制 (M42638)，SPOTFIRE RSP 阴性控制 (M42738)K230868SPOTFIRE® RSP 正負控制，SPOTFIRE® RSP 阳性控制，SPOTFIRE® RSP 阴性控制 K203680生物火JI控制面板M420

查看所有 13 項裝置 →

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。