FDA 510(k)

NeoBase 2 非衍生化 MSMS 套件

K 號：K193103 · 2020-02-07

決定日期2020-02-07

產品代碼NQL

諮詢委員會CH

決定相當於

器材摘要

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.

常見問題

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.

其他以 Perkinelmer, Inc. 為申請人之記錄

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K203035Eonis SCID-SMA 套件 K190335GSP新生兒全乳糖套件 K190266NeoLSD MSMS 套件 K161966PerkinElmer XRpad2 4336 HWC-M 平板式探測器 K161942PerkinElmer，XRpad2 3025 HWC-M 平板式探測器

相關器械（代碼：NQL）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K173568NeoBase 2 非衍生化 MSMS 套件Wallac Oy, Subsidiary of Perkinelmer, Inc.

官方來源

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