FDA 510(k)

Alinity c 三環類抗抑鬱藥試劑套件

K 號：K231020 · 2023-11-17

決定日期2023-11-17

產品代碼LFH

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決定相當於

器材摘要

Alinity c Tricyclic Antidepressants Reagent Kit is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corporation. It received FDA 510(k) clearance on 2023-11-17 under 510(k) number K231020. The device is classified under product code LFH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Alinity c Tricyclic Antidepressants Reagent Kit?

Alinity c Tricyclic Antidepressants Reagent Kit is a medical device that received FDA 510(k) clearance on 2023-11-17. The listed applicant is Microgenics Corporation. The 510(k) number is K231020.

When did Alinity c Tricyclic Antidepressants Reagent Kit receive FDA 510(k) clearance?

Alinity c Tricyclic Antidepressants Reagent Kit received FDA 510(k) clearance on 2023-11-17, under 510(k) number K231020.

Who is the listed applicant for Alinity c Tricyclic Antidepressants Reagent Kit?

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

What is the FDA product code for Alinity c Tricyclic Antidepressants Reagent Kit?

The FDA product code for Alinity c Tricyclic Antidepressants Reagent Kit is LFH.

其他以 Microgenics Corporation 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。

K243498Alinity c 苯二氮卓鹽試劑套件 K240670DRI Ecstasy Plus 測試 K231007CEDIA Heroin代謝物（6-AM）試驗 K213875DRI™ 三環類血清毒物測試 K211973DRI 可卡因代謝物測試 K192943CEDIA Heroin代謝物（6-AM）試劑

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相關器械（代碼：LFH）

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。

K213875DRI™ 三環類血清毒物測試Microgenics Corporation

官方來源

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