FDA 510(k)

StatStrip Xpress葡萄糖医院计量系统

K号: K182552 · 2018-12-13

决定日期2018-12-13

产品代码PZI

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

StatStrip Xpress Glucose Hospital Meter System is the device name listed in this FDA 510(k) record. The listed applicant is Nova Biomedical Corporation. It received FDA 510(k) clearance on 2018-12-13 under 510(k) number K182552. The device is classified under product code PZI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the StatStrip Xpress Glucose Hospital Meter System?

StatStrip Xpress Glucose Hospital Meter System is a medical device that received FDA 510(k) clearance on 2018-12-13. The listed applicant is Nova Biomedical Corporation. The 510(k) number is K182552.

When did StatStrip Xpress Glucose Hospital Meter System receive FDA 510(k) clearance?

StatStrip Xpress Glucose Hospital Meter System received FDA 510(k) clearance on 2018-12-13, under 510(k) number K182552.

Who is the listed applicant for StatStrip Xpress Glucose Hospital Meter System?

The FDA 510(k) record lists Nova Biomedical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StatStrip Xpress Glucose Hospital Meter System?

The FDA product code for StatStrip Xpress Glucose Hospital Meter System is PZI.

列明Nova Biomedical Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251281Nova Max Creat eGFR监控系统 K252206Nova Allegro UACR检测，Nova Allegro分析仪 K221326Nova Allegro HbA1c检测，Nova Allegro分析仪 K221813Nova Allegro UACR检测，Nova Allegro分析仪 K232075StatStrip葡萄糖医院计量系统 K221900Stat Profile Prime Plus分析系统

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官方来源

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