FDA 510(k)

Lumipulse G 孕酮-N 校准器

K号: K163546 · 2017-01-13

决定日期2017-01-13

产品代码JIT

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

Lumipulse G Progesterone-N Calibrators is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2017-01-13 under 510(k) number K163546. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Lumipulse G Progesterone-N Calibrators?

Lumipulse G Progesterone-N Calibrators is a medical device that received FDA 510(k) clearance on 2017-01-13. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K163546.

When did Lumipulse G Progesterone-N Calibrators receive FDA 510(k) clearance?

Lumipulse G Progesterone-N Calibrators received FDA 510(k) clearance on 2017-01-13, under 510(k) number K163546.

Who is the listed applicant for Lumipulse G Progesterone-N Calibrators?

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

What is the FDA product code for Lumipulse G Progesterone-N Calibrators?

The FDA product code for Lumipulse G Progesterone-N Calibrators is JIT.

列明Fujirebio Diagnostics,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。

K250925ADVIA Centaur 鳞状细胞癌相关抗原21-1 K242706Lumipulse G pTau217/β-淀粉样蛋白 1-42 血浆比值 K192524Lumipulse G CA15-3 K192380ST AIA-PACK BNP K200997Lumipulse G CA19-9-N K190702Lumipulse G 全部 PTH

查看所有 17 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。