FDA 510(k)

CAPI 3 Hb A1c

K号: K171537 · 2017-09-12

申请人Sebia

决定日期2017-09-12

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

CAPI 3 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 2017-09-12 under 510(k) number K171537. 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 CAPI 3 Hb A1c?

CAPI 3 Hb A1c is a medical device that received FDA 510(k) clearance on 2017-09-12. The listed applicant is Sebia. The 510(k) number is K171537.

When did CAPI 3 Hb A1c receive FDA 510(k) clearance?

CAPI 3 Hb A1c received FDA 510(k) clearance on 2017-09-12, under 510(k) number K171537.

Who is the listed applicant for CAPI 3 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 CAPI 3 Hb A1c?

The FDA product code for CAPI 3 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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