FDA 510(k)

BIOFIRE® SPOTFIRE® 呼吸 (R) 面板迷你版

K 號：K230719 · 2023-04-13

決定日期2023-04-13

產品代碼QOF

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

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K230719. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini?

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K230719.

When did BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini receive FDA 510(k) clearance?

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini received FDA 510(k) clearance on 2023-04-13, under 510(k) number K230719.

Who is the listed applicant for BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini?

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

What is the FDA product code for BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini?

The FDA product code for BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini is QOF.

其他以 Biofire Diagnostics, 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。

K243544BIOFIRE SPOTFIRE 呼吸道/喉痛面板迷你版 K243885BIOFIRE FILMARRAY 消化道（GI）面板中 K243759BIOFIRE 血培養識別 2 (BCID2) 面板 (RFIT-ASY-0147 (30 套) RFIT-ASY-0148 (6 套))K242367BIOFIRE FILMARRAY 消化道（GI）面板 K241194BIOFIRE SPOTFIRE 呼吸道/喉痛（R/ST）面板迷你版 K232954BIOFIRE SPOTFIRE 呼吸道/喉痛（R/ST）面板

查看所有 20 項裝置 →

相關器械（代碼：QOF）

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。

K261336Xpert 呼吸檢測組合Cepheid K263054BIOFIRE 呼吸面板 2.1 (RP2.1)Biofire Diagnostics K261837FINDER 流感A&B/SARS-CoV-2檢測Baebies, Inc.K252932快速PCR迷你呼吸道面板Autonomous Medical Devices Incorporated K252269FINDER 流感A&B/SARS-CoV-2檢測Baebies, Inc.K251742VELO 呼吸測試Lex Diagnostics Limited

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。