Sofia 疥病FIA，Sofia疥病控制套装
K号: K163713 · 2017-10-20
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决定日期2017-10-20
产品代码LSR
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决定实质等同
器械摘要
Sofia Lyme FIA, Sofia Lyme Control Set is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2017-10-20 under 510(k) number K163713. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sofia Lyme FIA, Sofia Lyme Control Set?
Sofia Lyme FIA, Sofia Lyme Control Set is a medical device that received FDA 510(k) clearance on 2017-10-20. The listed applicant is Quidel Corporation. The 510(k) number is K163713.
When did Sofia Lyme FIA, Sofia Lyme Control Set receive FDA 510(k) clearance?
Sofia Lyme FIA, Sofia Lyme Control Set received FDA 510(k) clearance on 2017-10-20, under 510(k) number K163713.
Who is the listed applicant for Sofia Lyme FIA, Sofia Lyme Control Set?
The FDA 510(k) record lists Quidel Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sofia Lyme FIA, Sofia Lyme Control Set?
The FDA product code for Sofia Lyme FIA, Sofia Lyme Control Set is LSR.
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Quidel Corporation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：LSR）
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。
K254295Sofia Lyme FIA；Sofia 2 螺旋菌 FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)K252627Lyme-ID IgG 测试；Bio-ID800Inanovate, Inc.K242872iDart Lyme IgM ImmunoBlot KitId-Fish Technology, Inc.K233367iDart莱姆病IgG免疫印迹试剂盒Id-Fish Technology, Inc.K230863宙斯索利纳斯伯氏螺旋体VlsE1/pepC10 IgG/IgM检测系统；宙斯索利纳斯伯氏螺旋体VlsE1/pepC10 IgG/IgM对照试剂盒Zeus ScientificK220016Viramed Borrela 全合一 ViraChip 检测试剂盒Viramed Biotech AG
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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