FDA 510(k)

ARCHITECT 弓形虫IgG

K号: K210596 · 2022-05-19

决定日期2022-05-19

产品代码LGD

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决定实质等同

器械摘要

ARCHITECT Toxo IgG is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K210596. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ARCHITECT Toxo IgG?

ARCHITECT Toxo IgG is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Abbott Laboratories. The 510(k) number is K210596.

When did ARCHITECT Toxo IgG receive FDA 510(k) clearance?

ARCHITECT Toxo IgG received FDA 510(k) clearance on 2022-05-19, under 510(k) number K210596.

Who is the listed applicant for ARCHITECT Toxo IgG?

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 ARCHITECT Toxo IgG?

The FDA product code for ARCHITECT Toxo IgG is LGD.

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。