ID NOW 流感A & B 2
K号: K190204 · 2019-03-18
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决定日期2019-03-18
产品代码OZE
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决定实质等同
器械摘要
ID NOW Influenza A & B 2 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 2019-03-18 under 510(k) number K190204. The device is classified under product code OZE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ID NOW Influenza A & B 2?
ID NOW Influenza A & B 2 is a medical device that received FDA 510(k) clearance on 2019-03-18. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K190204.
When did ID NOW Influenza A & B 2 receive FDA 510(k) clearance?
ID NOW Influenza A & B 2 received FDA 510(k) clearance on 2019-03-18, under 510(k) number K190204.
Who is the listed applicant for ID NOW Influenza A & B 2?
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 ID NOW Influenza A & B 2?
The FDA product code for ID NOW Influenza A & B 2 is OZE.
相关临床试验
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。
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。
K181853Alere BinaxNOW流感A & B卡2，Alere ReaderK173653Alere i 链球菌A 2，Alere i 仪器，Alere i 链球菌A 2控制拭子套装K173932Alere i 流感A & B，Alere i 链球菌A，Alere i RSV，Alere i 流感A & B 2K173502Alere 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
相关器械（代码：OZE）
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。
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官方来源
在 FDA 数据库中查看 →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。
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