FDA 510(k)

血液色素PLUS系统

K号: K163465 · 2017-09-08

决定日期2017-09-08

产品代码GKR

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决定实质等同

器械摘要

hemochroma PLUS System is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Inc.,. It received FDA 510(k) clearance on 2017-09-08 under 510(k) number K163465. The device is classified under product code GKR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the hemochroma PLUS System?

hemochroma PLUS System is a medical device that received FDA 510(k) clearance on 2017-09-08. The listed applicant is Immunostics Inc.,. The 510(k) number is K163465.

When did hemochroma PLUS System receive FDA 510(k) clearance?

hemochroma PLUS System received FDA 510(k) clearance on 2017-09-08, under 510(k) number K163465.

Who is the listed applicant for hemochroma PLUS System?

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

What is the FDA product code for hemochroma PLUS System?

The FDA product code for hemochroma PLUS System is GKR.

列明Immunostics 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。

K221817ALFIS维生素D，ALFIS-3分析仪 K182298血液色素PLUS系统 K163225AFIAS iFOB with AFIAS-50 K171484hema-screen 特定型 Gold K163554hema-screen ER XCEL 高清晰度粪便隐血检测

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