FDA 510(k)

ID NOW COVID-19 2.0

K号: K221925 · 2023-08-10

决定日期2023-08-10

产品代码QWR

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决定实质等同

器械摘要

ID NOW COVID-19 2.0 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 2023-08-10 under 510(k) number K221925. The device is classified under product code QWR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ID NOW COVID-19 2.0?

ID NOW COVID-19 2.0 is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K221925.

When did ID NOW COVID-19 2.0 receive FDA 510(k) clearance?

ID NOW COVID-19 2.0 received FDA 510(k) clearance on 2023-08-10, under 510(k) number K221925.

Who is the listed applicant for ID NOW COVID-19 2.0?

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 ID NOW COVID-19 2.0?

The FDA product code for ID NOW COVID-19 2.0 is QWR.

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 K243518BinaxNOW® COVID-19 抗原自测 K232775ID NOW 流感A & B 2 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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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。