FDA 510(k)

Diazyme 人κ游离轻链测定；Diazyme 人λ游离轻链测定

K号: K181438 · 2018-06-26

决定日期2018-06-26

产品代码DFH

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决定实质等同

器械摘要

Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories, Inc.. It received FDA 510(k) clearance on 2018-06-26 under 510(k) number K181438. 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 Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay?

Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay is a medical device that received FDA 510(k) clearance on 2018-06-26. The listed applicant is Diazyme Laboratories, Inc.. The 510(k) number is K181438.

When did Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay receive FDA 510(k) clearance?

Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay received FDA 510(k) clearance on 2018-06-26, under 510(k) number K181438.

Who is the listed applicant for Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay?

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

What is the FDA product code for Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay?

The FDA product code for Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay is DFH.

列明Diazyme Laboratories, Inc.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。

K253069脂蛋白(a)摩尔浓度测定 K252336Diazyme 免疫球蛋白A测定；Diazyme 免疫球蛋白G测定；Diazyme 免疫球蛋白M测定 K253358Diazyme 人κ（κ）游离轻链测定；Diazyme 人λ（λ）游离轻链测定 K243462Diazyme 颜色比色锂测定 K211648Diazyme 人κ游离轻链测定，Diazyme 人λ游离轻链测定 K220001Diazyme 人κ游离轻链测定，Diazyme 人λ游离轻链测定

查看所有 11 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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