FDA 510(k)

NeoLSD MSMS 套件

K 號：K190266 · 2019-05-03

決定日期2019-05-03

產品代碼PQW

諮詢委員會CH

決定相當於

器材摘要

NeoLSD 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 2019-05-03 under 510(k) number K190266. The device is classified under product code PQW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NeoLSD MSMS Kit?

NeoLSD MSMS Kit is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Perkinelmer, Inc.. The 510(k) number is K190266.

When did NeoLSD MSMS Kit receive FDA 510(k) clearance?

NeoLSD MSMS Kit received FDA 510(k) clearance on 2019-05-03, under 510(k) number K190266.

Who is the listed applicant for NeoLSD 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 NeoLSD MSMS Kit?

The FDA product code for NeoLSD MSMS Kit is PQW.

其他以 Perkinelmer, Inc. 為申請人之記錄

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。

K203035Eonis SCID-SMA 套件 K193103NeoBase 2 非衍生化 MSMS 套件 K190335GSP新生兒全乳糖套件 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：PQW）

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。

K173829NeoLSD MSMS 套件Wallac Oy, A Subsidiary of Perkinelmer

官方來源

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