FDA 510(k)

Optilite Freelite Mx Kappa Free Kit，Optilite Freelite Mx Lambda Free Kit

K号: K173732 · 2018-08-23

决定日期2018-08-23

产品代码DFH

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决定实质等同

器械摘要

Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2018-08-23 under 510(k) number K173732. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit?

Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit is a medical device that received FDA 510(k) clearance on 2018-08-23. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K173732.

When did Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit receive FDA 510(k) clearance?

Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit received FDA 510(k) clearance on 2018-08-23, under 510(k) number K173732.

Who is the listed applicant for Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit?

The FDA 510(k) record lists The Binding Site Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit?

The FDA product code for Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit is DFH.

列明The Binding Site Group , Ltd.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。

K250159免疫球蛋白同种型（GAM）用于EXENT分析器；EXENT分析器 K250549Optilite® Freelite Mx Kappa Free Kit；Optilite® Freelite Mx Lambda Free Kit K192116Human IgA 液体试剂套件用于 SPAPlus K191985Optilite IgA Kit K191635Optilite IgM Kit K191465Human IgM 套件用于 SPAPlus

查看所有 17 个设备 →

相关器械（代码：DFH）

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。

K253358Diazyme 人κ（κ）游离轻链测定；Diazyme 人λ（λ）游离轻链测定Diazyme Laboratories, Inc.K250549Optilite® Freelite Mx Kappa Free Kit；Optilite® Freelite Mx Lambda Free KitThe Binding Site Group , Ltd.K231601FLC Kappa，FLC Lambda，FLC 控制级别 1，FLC 控制级别 2Sebia K231290Optilite® Freelite® Kappa Free Kit，Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd.K210623FLC Kappa，FLC Lambda，FLC 控制级别 1，FLC 控制级别 2Sebia K211648Diazyme 人κ游离轻链测定，Diazyme 人λ游离轻链测定Diazyme Laboratories, Inc.

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