游离组织移植（FTT）ELISA测试系统
K号: K181017 · 2018-07-20
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决定日期2018-07-20
产品代码CDZ
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
Free Testosterone AccuBind ELISA Test System is the device name listed in this FDA 510(k) record. The listed applicant is Monobind, Inc.. It received FDA 510(k) clearance on 2018-07-20 under 510(k) number K181017. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Free Testosterone AccuBind ELISA Test System?
Free Testosterone AccuBind ELISA Test System is a medical device that received FDA 510(k) clearance on 2018-07-20. The listed applicant is Monobind, Inc.. The 510(k) number is K181017.
When did Free Testosterone AccuBind ELISA Test System receive FDA 510(k) clearance?
Free Testosterone AccuBind ELISA Test System received FDA 510(k) clearance on 2018-07-20, under 510(k) number K181017.
Who is the listed applicant for Free Testosterone AccuBind ELISA Test System?
The FDA 510(k) record lists Monobind, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Free Testosterone AccuBind ELISA Test System?
The FDA product code for Free Testosterone AccuBind ELISA Test System is CDZ.
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相关器械（代码：CDZ）
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官方来源
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