FDA 510(k)

Alere i 流感A & B，Alere i 流感A & B控制拭子套件，Alere i儀器

K 號：K163266 · 2016-12-21

決定日期2016-12-21

產品代碼OCC

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 i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument 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 2016-12-21 under 510(k) number K163266. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument?

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K163266.

When did Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument receive FDA 510(k) clearance?

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument received FDA 510(k) clearance on 2016-12-21, under 510(k) number K163266.

Who is the listed applicant for Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument?

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 i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument?

The FDA product code for Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument is OCC.

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 K173502Alere BinaxNOW流感A & B卡2，Alere Reader，Alere BinaxNOW流感A & B卡2控制拭子套件 K171792Alere i 流感A & B 2，Alere i儀器，Alere i 流感A & B控制拭子套件

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相關器械（代碼：OCC）

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。

K262747ID NOW 間接流感A&B 2；ID NOW RSV；ID NOW 链球菌A 2；ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.K254139BioCode® 呼吸道病原體面板 (RPP)Applied BioCode, Inc.K242613NxTAG® 呼吸道病原體檢測組合Luminex Molecular Diagnostics, Inc.K232775ID NOW 流感A&B 2Abbott Diagnostics Scarborough, Inc.K231017山貓融合AdV/hMPV/RV檢測試劑Hologic, Inc.K213822cobas Influenza A/B & RSV 遺伝子核酸檢測儀，適用於cobas Liat System系統Roche Molecular Systems, Inc.

官方來源

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