FDA 510(k)

N Latex FLC kappa 测定，N Latex FLC lambda 测定

K号: K182098 · 2018-11-01

申请人Siemens Healthcare Diagnostics Products GmbH

决定日期2018-11-01

产品代码DFH

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决定实质等同

器械摘要

N Latex FLC kappa assay, N Latex FLC lambda assay is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2018-11-01 under 510(k) number K182098. 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 N Latex FLC kappa assay, N Latex FLC lambda assay?

N Latex FLC kappa assay, N Latex FLC lambda assay is a medical device that received FDA 510(k) clearance on 2018-11-01. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K182098.

When did N Latex FLC kappa assay, N Latex FLC lambda assay receive FDA 510(k) clearance?

N Latex FLC kappa assay, N Latex FLC lambda assay received FDA 510(k) clearance on 2018-11-01, under 510(k) number K182098.

Who is the listed applicant for N Latex FLC kappa assay, N Latex FLC lambda assay?

The FDA 510(k) record lists Siemens Healthcare Diagnostics Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N Latex FLC kappa assay, N Latex FLC lambda assay?

The FDA product code for N Latex FLC kappa assay, N Latex FLC lambda assay is DFH.

列明Siemens Healthcare Diagnostics Products GmbH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。

K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)K233663N 抗人免疫球蛋白（IgG、IgA和IgM）抗血清 K220728vWF抗原 K212559CardioPhase® hsCRP K212379N Latex FLC kappa，N Latex FLC lambda K201496N Latex FLC kappa，N Latex FLC lambda

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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.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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