FDA 510(k)

BinaxNOW® COVID-19 抗原自测

K号: K243518 · 2025-02-11

决定日期2025-02-11

产品代码QYT

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决定实质等同

器械摘要

BinaxNOW™ COVID-19 Antigen Self Test is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics Scarborough, Inc.. It received FDA 510(k) clearance on 2025-02-11 under 510(k) number K243518. The device is classified under product code QYT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BinaxNOW™ COVID-19 Antigen Self Test?

BinaxNOW™ COVID-19 Antigen Self Test is a medical device that received FDA 510(k) clearance on 2025-02-11. The listed applicant is Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K243518.

When did BinaxNOW™ COVID-19 Antigen Self Test receive FDA 510(k) clearance?

BinaxNOW™ COVID-19 Antigen Self Test received FDA 510(k) clearance on 2025-02-11, under 510(k) number K243518.

Who is the listed applicant for BinaxNOW™ COVID-19 Antigen Self Test?

FDA 510(k)记录将阿伯特诊断斯卡伯勒公司（Abbott Diagnostics Scarborough, Inc.）列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for BinaxNOW™ COVID-19 Antigen Self Test?

The FDA product code for BinaxNOW™ COVID-19 Antigen Self Test is QYT.

列明Abbott Diagnostics 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。

K262747ID NOW 流感A & B 2；ID NOW RSV；ID NOW 链球菌A 2；ID NOW COVID-19 2.0 K250273BinaxNOW COVID-19 Ag 卡 K232775ID NOW 流感A & B 2 K221925ID NOW COVID-19 2.0 K220801ID Now 仪器，ID Now 流感A & B 2，ID NOW 链球菌A 2 K191534ID NOW 流感A & B 2

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