FDA 510(k)

i-STAT TBI 血浆模块，适用于 i-STAT Alinity 系统

K号: K201778 · 2021-01-08

决定日期2021-01-08

产品代码QAT

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决定实质等同

器械摘要

i-STAT TBI Plasma cartridge with the 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 2021-01-08 under 510(k) number K201778. The device is classified under product code QAT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the i-STAT TBI Plasma cartridge with the i-STAT Alinity System?

i-STAT TBI Plasma cartridge with the i-STAT Alinity System is a medical device that received FDA 510(k) clearance on 2021-01-08. The listed applicant is Abbott Laboratories. The 510(k) number is K201778.

When did i-STAT TBI Plasma cartridge with the i-STAT Alinity System receive FDA 510(k) clearance?

i-STAT TBI Plasma cartridge with the i-STAT Alinity System received FDA 510(k) clearance on 2021-01-08, under 510(k) number K201778.

Who is the listed applicant for i-STAT TBI Plasma cartridge with the 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 TBI Plasma cartridge with the i-STAT Alinity System?

The FDA product code for i-STAT TBI Plasma cartridge with the i-STAT Alinity System is QAT.

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。