Piccolo 钾测试系统
K号: K200865 · 2021-10-20
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申请人Abaxis, Inc.
决定日期2021-10-20
产品代码MZV
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Piccolo Potassium Test System is the device name listed in this FDA 510(k) record. The listed applicant is Abaxis, Inc.. It received FDA 510(k) clearance on 2021-10-20 under 510(k) number K200865. The device is classified under product code MZV. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Piccolo Potassium Test System?
Piccolo Potassium Test System is a medical device that received FDA 510(k) clearance on 2021-10-20. The listed applicant is Abaxis, Inc.. The 510(k) number is K200865.
When did Piccolo Potassium Test System receive FDA 510(k) clearance?
Piccolo Potassium Test System received FDA 510(k) clearance on 2021-10-20, under 510(k) number K200865.
Who is the listed applicant for Piccolo Potassium Test System?
The FDA 510(k) record lists Abaxis, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Piccolo Potassium Test System?
The FDA product code for Piccolo Potassium Test System is MZV.
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