FDA 510(k)

阿司匹林

K 號：K202644 · 2022-02-18

決定日期2022-02-18

產品代碼LDP

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決定相當於

器材摘要

Acetaminophen is the device name listed in this FDA 510(k) record. The listed applicant is Sekisui Diagnostics P.E.I., Inc.. It received FDA 510(k) clearance on 2022-02-18 under 510(k) number K202644. The device is classified under product code LDP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Acetaminophen?

Acetaminophen is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Sekisui Diagnostics P.E.I., Inc.. The 510(k) number is K202644.

When did Acetaminophen receive FDA 510(k) clearance?

Acetaminophen received FDA 510(k) clearance on 2022-02-18, under 510(k) number K202644.

Who is the listed applicant for Acetaminophen?

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

What is the FDA product code for Acetaminophen?

The FDA product code for Acetaminophen is LDP.

其他以 Sekisui Diagnostics P.E.I., 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。

K182702SEKURE 磷酸激酶測試 K180835SEKURE 阿斯匹林 L3K 檢測 K173206SEKURE HbA1c 檢測儀 K163078DC-UIBC-CAL

相關器械（代碼：LDP）

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。

K261364Atellica CH 阿斯匹林 2 (ACTM)Siemens Healthcare Diagnostics, Inc.K180835SEKURE 阿斯匹林 L3K 檢測Sekisui Diagnostics P.E.I., Inc.

官方來源

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