FDA 510(k)

ST AIA-PACK hsE2 校准器套件

K号: K160113 · 2016-02-17

决定日期2016-02-17

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

ST AIA-PACK hsE2 Calibrator Set is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Bioscience, Inc.. It received FDA 510(k) clearance on 2016-02-17 under 510(k) number K160113. 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 ST AIA-PACK hsE2 Calibrator Set?

ST AIA-PACK hsE2 Calibrator Set is a medical device that received FDA 510(k) clearance on 2016-02-17. The listed applicant is Tosoh Bioscience, Inc.. The 510(k) number is K160113.

When did ST AIA-PACK hsE2 Calibrator Set receive FDA 510(k) clearance?

ST AIA-PACK hsE2 Calibrator Set received FDA 510(k) clearance on 2016-02-17, under 510(k) number K160113.

Who is the listed applicant for ST AIA-PACK hsE2 Calibrator Set?

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

What is the FDA product code for ST AIA-PACK hsE2 Calibrator Set?

The FDA product code for ST AIA-PACK hsE2 Calibrator Set is JIT.

列明Tosoh Bioscience, 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。

K250073东芝自动糖化血红蛋白分析仪 HLC-723GR01 K211199ST AIA-PACK BNP 测定 K200904东芝自动糖化血红蛋白分析仪 HLC-723G8

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