FDA 510(k)

ARK Methotrexate II Assay

K 號：K232017 · 2023-12-20

決定日期2023-12-20

產品代碼LAO

決定相當於

器材摘要

ARK Methotrexate II Assay is the device name listed in this FDA 510(k) record. The listed applicant is Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K232017. The device is classified under product code LAO. FDA Decision: Substantially Equivalent.

常見問題

What is the ARK Methotrexate II Assay?

ARK Methotrexate II Assay is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Ark Diagnostics, Inc.. The 510(k) number is K232017.

When did ARK Methotrexate II Assay receive FDA 510(k) clearance?

ARK Methotrexate II Assay received FDA 510(k) clearance on 2023-12-20, under 510(k) number K232017.

Who is the listed applicant for ARK Methotrexate II Assay?

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

What is the FDA product code for ARK Methotrexate II Assay?

The FDA product code for ARK Methotrexate II Assay is LAO.

其他以 Ark Diagnostics, Inc. 為申請人之記錄

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相關器械（代碼：LAO）

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。

K233454網上TDM MethotrexateRoche Diagnostics Operations K163359ARK Methotrexate AssayArk Diagnostics, Inc.

官方來源

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