FDA 510(k)

Alinity c 苯二氮卓鹽試劑套件

K 號：K243498 · 2024-12-11

決定日期2024-12-11

產品代碼JXM

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決定相當於

器材摘要

Alinity c Benzodiazepines 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 2024-12-11 under 510(k) number K243498. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Alinity c Benzodiazepines Reagent Kit?

Alinity c Benzodiazepines Reagent Kit is a medical device that received FDA 510(k) clearance on 2024-12-11. The listed applicant is Microgenics Corporation. The 510(k) number is K243498.

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

Alinity c Benzodiazepines Reagent Kit received FDA 510(k) clearance on 2024-12-11, under 510(k) number K243498.

Who is the listed applicant for Alinity c Benzodiazepines 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 Benzodiazepines Reagent Kit?

The FDA product code for Alinity c Benzodiazepines Reagent Kit is JXM.

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。

K240670DRI Ecstasy Plus 測試 K231020Alinity c 三環類抗抑鬱藥試劑套件 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：JXM）

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。

K221765網上資料 Benzodiazepines IIRoche Diagnostics K190968CEDIA 苯二氮平試驗Microgenics Corporation K173963DRI 苯二氮平試驗Microgenics Corporation K163590Psychemedics 髮絲中苯二氮䓬類微板酶免疫測試Psychemedics Corporation K163704Healgen 多藥尿液檢測杯；Healgen 多藥尿液檢測濾紙卡Healgen Scientific,, LLC K153597Healgen多藥尿液檢測杯，Healgen多藥尿液檢測濾紙卡Healgen Scientific,, LLC

官方來源

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