FDA 510(k)

無細胞DNA BCT

K 號：K231776 · 2024-07-26

決定日期2024-07-26

產品代碼QMA

諮詢委員會CH

決定相當於

器材摘要

Cell-Free DNA BCT is the device name listed in this FDA 510(k) record. The listed applicant is Streck, Inc.. It received FDA 510(k) clearance on 2024-07-26 under 510(k) number K231776. The device is classified under product code QMA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cell-Free DNA BCT?

Cell-Free DNA BCT is a medical device that received FDA 510(k) clearance on 2024-07-26. The listed applicant is Streck, Inc.. The 510(k) number is K231776.

When did Cell-Free DNA BCT receive FDA 510(k) clearance?

Cell-Free DNA BCT received FDA 510(k) clearance on 2024-07-26, under 510(k) number K231776.

Who is the listed applicant for Cell-Free DNA BCT?

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

What is the FDA product code for Cell-Free DNA BCT?

The FDA product code for Cell-Free DNA BCT is QMA.

其他以 Streck, Inc. 為申請人之記錄

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K212576MDx-Chex用於BCID2

官方來源

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