FDA 510(k)

Alere i RSV，Alere i儀器，Alere i RSV控制拭子套件

K 號：K161375 · 2016-08-18

決定日期2016-08-18

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 RSV, Alere i Instrument, Alere i RSV 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 2016-08-18 under 510(k) number K161375. 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 RSV, Alere i Instrument, Alere i RSV Control Swab Kit?

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K161375.

When did Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit receive FDA 510(k) clearance?

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit received FDA 510(k) clearance on 2016-08-18, under 510(k) number K161375.

Who is the listed applicant for Alere i RSV, Alere i Instrument, Alere i RSV 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 i RSV, Alere i Instrument, Alere i RSV Control Swab Kit?

The FDA product code for Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit 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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