FDA 510(k)

Alere i 链球菌A 2，Alere i 仪器，Alere i 链球菌A 2控制拭子套装

K号: K173653 · 2018-05-02

决定日期2018-05-02

产品代码PGX

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决定实质等同

器械摘要

Alere i Strep A 2, Alere i instrument, Alere i Strep A 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 2018-05-02 under 510(k) number K173653. The device is classified under product code PGX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit?

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit is a medical device that received FDA 510(k) clearance on 2018-05-02. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K173653.

When did Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit receive FDA 510(k) clearance?

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit received FDA 510(k) clearance on 2018-05-02, under 510(k) number K173653.

Who is the listed applicant for Alere i Strep A 2, Alere i instrument, Alere i Strep A 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 i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit?

The FDA product code for Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit is PGX.

列明Alere Scarborough, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K190204ID NOW 流感A & B 2 K181853Alere BinaxNOW流感A & B卡2，Alere Reader 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控制拭子套装 K171792Alere i 流感A & B 2，Alere i 仪器，Alere i 流感A & B控制拭子套装 K162642Alere BinaxNOW流感A & B卡2，Alere Reader，Alere BinaxNOW流感A & B卡2控制拭子套装

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