FDA 510(k)

SmartLyte® Plus 電解質分析儀 Na+/K+/Cl-/Ca++/Li+

K 號：K200544 · 2020-10-01

決定日期2020-10-01

產品代碼CEM

諮詢委員會CH

決定相當於

器材摘要

SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ is the device name listed in this FDA 510(k) record. The listed applicant is Diamond Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-10-01 under 510(k) number K200544. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+?

SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ is a medical device that received FDA 510(k) clearance on 2020-10-01. The listed applicant is Diamond Diagnostics, Inc.. The 510(k) number is K200544.

When did SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ receive FDA 510(k) clearance?

SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ received FDA 510(k) clearance on 2020-10-01, under 510(k) number K200544.

Who is the listed applicant for SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+?

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

What is the FDA product code for SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+?

The FDA product code for SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ is CEM.

相關器械（代碼：CEM）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：CEM）

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