FDA 510(k)

i-STAT 血细胞比容测试，配备 i-STAT Alinity 系统

K号: K163342 · 2017-08-22

决定日期2017-08-22

产品代码JPI

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

i-STAT Hematocrit test with i-STAT Alinity System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2017-08-22 under 510(k) number K163342. The device is classified under product code JPI. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the i-STAT Hematocrit test with i-STAT Alinity System?

i-STAT Hematocrit test with i-STAT Alinity System is a medical device that received FDA 510(k) clearance on 2017-08-22. The listed applicant is Abbott Laboratories. The 510(k) number is K163342.

When did i-STAT Hematocrit test with i-STAT Alinity System receive FDA 510(k) clearance?

i-STAT Hematocrit test with i-STAT Alinity System received FDA 510(k) clearance on 2017-08-22, under 510(k) number K163342.

Who is the listed applicant for i-STAT Hematocrit test with i-STAT Alinity System?

FDA 510(k)记录显示，申请人为阿伯特实验室。这本身并不能确立该设备的制造商。

What is the FDA product code for i-STAT Hematocrit test with i-STAT Alinity System?

The FDA product code for i-STAT Hematocrit test with i-STAT Alinity System is JPI.

列明Abbott Laboratories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。

K262156抗HCV Next K252424抗HCV Next K243500ARCHITECT 链霉素 K243168Alinity i 风疹IgG K243283Alinity h系列系统 K233932Alinity i Toxo IgM

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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。