FDA 510(k)

Optilite® Freelite Mx Kappa Free Kit；Optilite® Freelite Mx Lambda Free Kit

K号: K250549 · 2025-05-23

决定日期2025-05-23

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 2025-05-23 under 510(k) number K250549. 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 2025-05-23. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K250549.

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 2025-05-23, under 510(k) number K250549.

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 K192116Human IgA 液体试剂套件用于 SPAPlus K191985Optilite IgA Kit K191635Optilite IgM Kit K191465Human IgM 套件用于 SPAPlus K190686Optilite IgM CSF Kit

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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.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.K220001Diazyme 人κ游离轻链测定，Diazyme 人λ游离轻链测定Diazyme Laboratories, Inc.

官方来源

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