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FDA 510(k)

YSI 2900C 生化分析仪

K 號:K210933 · 2024-09-30

申請人Ysi, Inc.
決定日期2024-09-30
產品代碼CGA
諮詢委員會CH
決定相當於

器材摘要

YSI 2900C Biochemistry Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Ysi, Inc.. It received FDA 510(k) clearance on 2024-09-30 under 510(k) number K210933. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the YSI 2900C Biochemistry Analyzer?

YSI 2900C Biochemistry Analyzer is a medical device that received FDA 510(k) clearance on 2024-09-30. The listed applicant is Ysi, Inc.. The 510(k) number is K210933.

When did YSI 2900C Biochemistry Analyzer receive FDA 510(k) clearance?

YSI 2900C Biochemistry Analyzer received FDA 510(k) clearance on 2024-09-30, under 510(k) number K210933.

Who is the listed applicant for YSI 2900C Biochemistry Analyzer?

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

What is the FDA product code for YSI 2900C Biochemistry Analyzer?

The FDA product code for YSI 2900C Biochemistry Analyzer is CGA.

相關臨床試驗

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相關器械(代碼:CGA)

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。

官方來源

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