FDA 510(k)

CAPILLARYS Hb A1c

K号: K171861 · 2018-02-07

申请人Sebia

决定日期2018-02-07

产品代码PDJ

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

CAPILLARYS Hb A1c is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2018-02-07 under 510(k) number K171861. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CAPILLARYS Hb A1c?

CAPILLARYS Hb A1c is a medical device that received FDA 510(k) clearance on 2018-02-07. The listed applicant is Sebia. The 510(k) number is K171861.

When did CAPILLARYS Hb A1c receive FDA 510(k) clearance?

CAPILLARYS Hb A1c received FDA 510(k) clearance on 2018-02-07, under 510(k) number K171861.

Who is the listed applicant for CAPILLARYS Hb A1c?

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 CAPILLARYS Hb A1c?

The FDA product code for CAPILLARYS Hb A1c is PDJ.

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。

K232027CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument K231601FLC Kappa，FLC Lambda，FLC 控制级别 1，FLC 控制级别 2 K210623FLC Kappa，FLC Lambda，FLC 控制级别 1，FLC 控制级别 2 K203184HYDRASHIFT 2/4 isatuximab K192095CAPI 3 Immunotyping, Capillarys 3 Tera K190851HYDRASHIFT 2/4 daratumumab

查看所有 12 个设备 →

相关器械（代码：PDJ）

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。

K252749Medconn 8K 糖化血红蛋白测试系统Shanghai Medconn Medical Technology Co., Ltd.K250073东芝自动糖化血红蛋白分析仪 HLC-723GR01Tosoh Bioscience, Inc.K242911Medconn 糖化血红蛋白测试系统Shanghai Medconn Medical Technology Co., Ltd.K220999Hipro 糖化血红蛋白 (HbA1c) 测试系统Shijiazhuang Hipro Biotechnology Co., Ltd.K200904东芝自动糖化血红蛋白分析仪 HLC-723G8Tosoh Bioscience, Inc.K200256ADVIA 化学酶法血红蛋白Ale (Alc_E) 测定Siemens Healthcare Diagnostics, Inc.

官方来源

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