FDA 510(k)

InTray GC

K 號：K210511 · 2021-10-20

決定日期2021-10-20

產品代碼JTY

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

InTray GC is the device name listed in this FDA 510(k) record. The listed applicant is Biomed Diagnostics Incorporated. It received FDA 510(k) clearance on 2021-10-20 under 510(k) number K210511. The device is classified under product code JTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the InTray GC?

InTray GC is a medical device that received FDA 510(k) clearance on 2021-10-20. The listed applicant is Biomed Diagnostics Incorporated. The 510(k) number is K210511.

When did InTray GC receive FDA 510(k) clearance?

InTray GC received FDA 510(k) clearance on 2021-10-20, under 510(k) number K210511.

Who is the listed applicant for InTray GC?

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

What is the FDA product code for InTray GC?

The FDA product code for InTray GC is JTY.

官方來源

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器材摘要

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