FDA 510(k)

D-10血红蛋白A1c程序

K号: K161687 · 2016-10-14

决定日期2016-10-14

产品代码PDJ

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决定实质等同

器械摘要

D-10 Hemoglobin A1c Program is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K161687. 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 D-10 Hemoglobin A1c Program?

D-10 Hemoglobin A1c Program is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K161687.

When did D-10 Hemoglobin A1c Program receive FDA 510(k) clearance?

D-10 Hemoglobin A1c Program received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161687.

Who is the listed applicant for D-10 Hemoglobin A1c Program?

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

What is the FDA product code for D-10 Hemoglobin A1c Program?

The FDA product code for D-10 Hemoglobin A1c Program is PDJ.

列明Bio-Rad Laboratories, 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。

K181661QXDx BCR-ABL %IS 套件，用于QXDx AutoDG ddPCR 系统 K171664新生儿血红蛋白系统中的血红蛋白变异体系统与GDM和HbReview软件

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。

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