FDA 510(k)

ISE試劑，葡萄糖，CRP膠乳，DxC 500 AU臨床化學分析儀

K 號：K220977 · 2023-07-20

申請人Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.

決定日期2023-07-20

產品代碼JGS

諮詢委員會CH

決定相當於

器材摘要

ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2023-07-20 under 510(k) number K220977. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer?

ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer is a medical device that received FDA 510(k) clearance on 2023-07-20. The listed applicant is Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. The 510(k) number is K220977.

When did ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer receive FDA 510(k) clearance?

ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer received FDA 510(k) clearance on 2023-07-20, under 510(k) number K220977.

Who is the listed applicant for ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer?

The FDA 510(k) record lists Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer?

The FDA product code for ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer is JGS.

其他以 Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. 為申請人之記錄

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相關器械（代碼：JGS）

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。

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