FDA 510(k)

ONLINE TDM 美罗华

K号: K233454 · 2024-02-20

决定日期2024-02-20

产品代码LAO

决定实质等同

器械摘要

ONLINE TDM Methotrexate is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations. It received FDA 510(k) clearance on 2024-02-20 under 510(k) number K233454. The device is classified under product code LAO. FDA Decision: Substantially Equivalent.

常见问题

What is the ONLINE TDM Methotrexate?

ONLINE TDM Methotrexate is a medical device that received FDA 510(k) clearance on 2024-02-20. The listed applicant is Roche Diagnostics Operations. The 510(k) number is K233454.

When did ONLINE TDM Methotrexate receive FDA 510(k) clearance?

ONLINE TDM Methotrexate received FDA 510(k) clearance on 2024-02-20, under 510(k) number K233454.

Who is the listed applicant for ONLINE TDM Methotrexate?

The FDA 510(k) record lists Roche Diagnostics Operations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONLINE TDM Methotrexate?

The FDA product code for ONLINE TDM Methotrexate is LAO.

列明Roche Diagnostics Operations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。

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