FDA 510(k)

網上資料 Benzodiazepines II

K 號：K221765 · 2022-12-23

決定日期2022-12-23

產品代碼JXM

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決定相當於

器材摘要

ONLINE DAT Benzodiazepines II is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2022-12-23 under 510(k) number K221765. 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 ONLINE DAT Benzodiazepines II?

ONLINE DAT Benzodiazepines II is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is Roche Diagnostics. The 510(k) number is K221765.

When did ONLINE DAT Benzodiazepines II receive FDA 510(k) clearance?

ONLINE DAT Benzodiazepines II received FDA 510(k) clearance on 2022-12-23, under 510(k) number K221765.

Who is the listed applicant for ONLINE DAT Benzodiazepines II?

FDA 510(k) 記錄將羅氏醫學診斷列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for ONLINE DAT Benzodiazepines II?

The FDA product code for ONLINE DAT Benzodiazepines II is JXM.