FDA 510(k)

X100 全视野外周血涂片（PBS）应用

K号: K201301 · 2020-10-02

决定日期2020-10-02

产品代码JOY

咨询委员会HE 请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

X100 with Full Field Peripheral Blood Smear (PBS) Application is the device name listed in this FDA 510(k) record. The listed applicant is Scopio Labs , Ltd.. It received FDA 510(k) clearance on 2020-10-02 under 510(k) number K201301. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the X100 with Full Field Peripheral Blood Smear (PBS) Application?

X100 with Full Field Peripheral Blood Smear (PBS) Application is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is Scopio Labs , Ltd.. The 510(k) number is K201301.

When did X100 with Full Field Peripheral Blood Smear (PBS) Application receive FDA 510(k) clearance?

X100 with Full Field Peripheral Blood Smear (PBS) Application received FDA 510(k) clearance on 2020-10-02, under 510(k) number K201301.

Who is the listed applicant for X100 with Full Field Peripheral Blood Smear (PBS) Application?

The FDA 510(k) record lists Scopio Labs , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X100 with Full Field Peripheral Blood Smear (PBS) Application?

The FDA product code for X100 with Full Field Peripheral Blood Smear (PBS) Application is JOY.

列明Scopio Labs , Ltd.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。

K243144X100/X100HT 全场外周血涂片（PBS）应用 K220013X100HT带滑动加载器，全视野外周血涂片（PBS）应用

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。