Osom Ultra Plus 流感A&B测试套件
K号: K192719 · 2020-04-03
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决定日期2020-04-03
产品代码PSZ
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器械摘要
Osom Ultra Plus Flu A&B Test Kit is the device name listed in this FDA 510(k) record. The listed applicant is SEKISUI Diagnostics, LLC. It received FDA 510(k) clearance on 2020-04-03 under 510(k) number K192719. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Osom Ultra Plus Flu A&B Test Kit?
Osom Ultra Plus Flu A&B Test Kit is a medical device that received FDA 510(k) clearance on 2020-04-03. The listed applicant is SEKISUI Diagnostics, LLC. The 510(k) number is K192719.
When did Osom Ultra Plus Flu A&B Test Kit receive FDA 510(k) clearance?
Osom Ultra Plus Flu A&B Test Kit received FDA 510(k) clearance on 2020-04-03, under 510(k) number K192719.
Who is the listed applicant for Osom Ultra Plus Flu A&B Test Kit?
The FDA 510(k) record lists SEKISUI Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Osom Ultra Plus Flu A&B Test Kit?
The FDA product code for Osom Ultra Plus Flu A&B Test Kit is PSZ.
相关临床试验
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列明SEKISUI Diagnostics, LLC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：PSZ）
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。
K254262索菲亚流感A+B快速免疫分析；索菲亚呼吸道合胞病毒快速免疫分析；索菲亚链球菌A+快速免疫分析Ortho Clinical Diagnostics Inc. (QuidelOrtho)K252283Nano-Check流感A+B测试Nano-Ditech CorporationK250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.K241188Acucy®流感A&B测试与Acucy® 2系统SEKISUI Diagnostics, LLCK232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBdK223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd
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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