FDA 510(k)

FLC Kappa，FLC Lambda，FLC 控制级别 1，FLC 控制级别 2

K号: K210623 · 2022-11-18

申请人Sebia

决定日期2022-11-18

产品代码DFH

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决定实质等同

器械摘要

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K210623. 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 FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2?

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Sebia. The 510(k) number is K210623.

When did FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 receive FDA 510(k) clearance?

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 received FDA 510(k) clearance on 2022-11-18, under 510(k) number K210623.

Who is the listed applicant for FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2?

The FDA 510(k) record lists Sebia as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2?

The FDA product code for FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 is DFH.

列明Sebia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。

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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.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.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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