FDA 510(k)

DRI™ 三環類血清毒物測試

K 號：K213875 · 2022-12-21

決定日期2022-12-21

產品代碼LFH

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決定相當於

器材摘要

DRI TM Tricyclics Serum Tox Assay is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corporation. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K213875. 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 DRI TM Tricyclics Serum Tox Assay?

DRI TM Tricyclics Serum Tox Assay is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Microgenics Corporation. The 510(k) number is K213875.

When did DRI TM Tricyclics Serum Tox Assay receive FDA 510(k) clearance?

DRI TM Tricyclics Serum Tox Assay received FDA 510(k) clearance on 2022-12-21, under 510(k) number K213875.

Who is the listed applicant for DRI TM Tricyclics Serum Tox Assay?

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 DRI TM Tricyclics Serum Tox Assay?

The FDA product code for DRI TM Tricyclics Serum Tox Assay 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。

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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。

K231020Alinity c 三環類抗抑鬱藥試劑套件Microgenics Corporation

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。