FDA 510(k)

N Latex FLC kappa，N Latex FLC lambda

K号: K212379 · 2022-03-02

申请人Siemens Healthcare Diagnostics Products GmbH

决定日期2022-03-02

产品代码DFH

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决定实质等同

器械摘要

N Latex FLC kappa, N Latex FLC lambda 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 2022-03-02 under 510(k) number K212379. 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, N Latex FLC lambda?

N Latex FLC kappa, N Latex FLC lambda is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K212379.

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

N Latex FLC kappa, N Latex FLC lambda received FDA 510(k) clearance on 2022-03-02, under 510(k) number K212379.

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

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, N Latex FLC lambda?

The FDA product code for N Latex FLC kappa, N Latex FLC lambda 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 K201496N Latex FLC kappa，N Latex FLC lambda K193047N 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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