FDA 510(k)

Alere BinaxNOW流感A & B卡2，Alere Reader，Alere BinaxNOW流感A & B卡2控制拭子套件

K 號：K173502 · 2017-12-13

決定日期2017-12-13

產品代碼PSZ

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

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit is the device name listed in this FDA 510(k) record. The listed applicant is Alere Scarborough, Inc.. It received FDA 510(k) clearance on 2017-12-13 under 510(k) number K173502. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit?

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit is a medical device that received FDA 510(k) clearance on 2017-12-13. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K173502.

When did Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit receive FDA 510(k) clearance?

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit received FDA 510(k) clearance on 2017-12-13, under 510(k) number K173502.

Who is the listed applicant for Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit?

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

What is the FDA product code for Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit?

The FDA product code for Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit is PSZ.

其他以 Alere Scarborough, 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。

K190204ID NOW 流感A&B 2 K181853Alere BinaxNOW流感A & B卡2，Alere Reader K173653Alere i 链球菌A 2，Alere i儀器，Alere i 链球菌A 2控制拭子套件 K173932Alere i 流感A & B，Alere i 链球菌A，Alere i RSV，Alere i 流感A & B 2 K171792Alere i 流感A & B 2，Alere i儀器，Alere i 流感A & B控制拭子套件 K162642Alere BinaxNOW流感A & B卡2，Alere Reader，Alere BinaxNOW流感A & B卡2控制拭子套件

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相關器械（代碼：PSZ）

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。

K254262索菲亞流感A+B FIA；索菲亞呼吸道合胞病毒FIA；索菲亞溶血性链球菌A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho)K252283奈諾檢流感A+B檢測試劑Nano-Ditech Corporation K250398Innovita 流感A/B 抗原快速檢測Innovita (Tangshan) Biological Technology Co., Ltd.K241188Acucy® 開放性流感 A&B 檢測與 Acucy® 2 系統SEKISUI Diagnostics, LLC K232434BD Veritor™ 系統快速檢測流感A+B CLIA Waived KitBd K223016BD Veritor™ 系統快速檢測流感A+B CLIA-Waived KitBd

官方來源

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