FDA 510(k)

網上TDM Methotrexate

K 號：K233454 · 2024-02-20

決定日期2024-02-20

產品代碼LAO

決定相當於

器材摘要

ONLINE TDM Methotrexate is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations. It received FDA 510(k) clearance on 2024-02-20 under 510(k) number K233454. The device is classified under product code LAO. FDA Decision: Substantially Equivalent.

常見問題

What is the ONLINE TDM Methotrexate?

ONLINE TDM Methotrexate is a medical device that received FDA 510(k) clearance on 2024-02-20. The listed applicant is Roche Diagnostics Operations. The 510(k) number is K233454.

When did ONLINE TDM Methotrexate receive FDA 510(k) clearance?

ONLINE TDM Methotrexate received FDA 510(k) clearance on 2024-02-20, under 510(k) number K233454.

Who is the listed applicant for ONLINE TDM Methotrexate?

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

What is the FDA product code for ONLINE TDM Methotrexate?

The FDA product code for ONLINE TDM Methotrexate is LAO.

其他以 Roche Diagnostics Operations 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。

K241220Tina-quant 脂質蛋白(a) Gen.2 摩爾濃度 K163633cobas HbA1c 測試，cobas b 101 系統

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。

K232017ARK Methotrexate II AssayArk Diagnostics, Inc.K163359ARK Methotrexate AssayArk Diagnostics, Inc.

官方來源

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