Status® COVID-19/流感A&B
K号: K251538 · 2025-11-14
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决定日期2025-11-14
产品代码SCA
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决定实质等同
器械摘要
Status™ COVID-19/Flu A&B is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 2025-11-14 under 510(k) number K251538. The device is classified under product code SCA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Status™ COVID-19/Flu A&B?
Status™ COVID-19/Flu A&B is a medical device that received FDA 510(k) clearance on 2025-11-14. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K251538.
When did Status™ COVID-19/Flu A&B receive FDA 510(k) clearance?
Status™ COVID-19/Flu A&B received FDA 510(k) clearance on 2025-11-14, under 510(k) number K251538.
Who is the listed applicant for Status™ COVID-19/Flu A&B?
The FDA 510(k) record lists Princeton BioMeditech Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Status™ COVID-19/Flu A&B?
The FDA product code for Status™ COVID-19/Flu A&B is SCA.
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Princeton BioMeditech Corp.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。
相关器械（代码：SCA）
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。
K261212Flowflex Plus RSV + 流感A/B + COVID快速测试ACON Laboratories, Inc.K251085iHealth流感A&B/COVID-19/RSV快速检测；iHealth流感A&B/COVID-19/RSV快速检测专业版Ihealth Labs, Inc.K251092iHealth 流感A&B/COVID-19 快速测试；iHealth 流感A&B/COVID-19 快速测试专业版Ihealth Labs, Inc.K251749Flowflex Plus RSV + Flu A/B + COVID Home TestACON Laboratories, Inc.K251604CareSuperb COVID-19/流感 A&B 抗原组合家用检测Access Bio, Inc.K251563WELLlife 流感A&B家用检测仪；WELLlife 流感A&B检测仪Wondfo USA Co, Ltd.
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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