FDA 510(k)

NeoBase 2 非衍生物 MSMS 试剂盒

K号: K193103 · 2020-02-07

决定日期2020-02-07

产品代码NQL

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

NeoBase 2 Non-derivatized MSMS Kit is the device name listed in this FDA 510(k) record. The listed applicant is Perkinelmer, Inc.. It received FDA 510(k) clearance on 2020-02-07 under 510(k) number K193103. The device is classified under product code NQL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NeoBase 2 Non-derivatized MSMS Kit?

NeoBase 2 Non-derivatized MSMS Kit is a medical device that received FDA 510(k) clearance on 2020-02-07. The listed applicant is Perkinelmer, Inc.. The 510(k) number is K193103.

When did NeoBase 2 Non-derivatized MSMS Kit receive FDA 510(k) clearance?

NeoBase 2 Non-derivatized MSMS Kit received FDA 510(k) clearance on 2020-02-07, under 510(k) number K193103.

Who is the listed applicant for NeoBase 2 Non-derivatized MSMS Kit?

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

What is the FDA product code for NeoBase 2 Non-derivatized MSMS Kit?

The FDA product code for NeoBase 2 Non-derivatized MSMS Kit is NQL.

列明Perkinelmer, 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。

K203035Eonis SCID-SMA 套件 K190335GSP Neonatal Total Galactose kit K190266NeoLSD MSMS 试剂盒 K161966PerkinElmer XRpad2 4336 HWC-M 平板探测器 K161942PerkinElmer, XRpad2 3025 HWC-M 平板探测器

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。