FDA 510(k)

Elecsys Anti-HBc IgM

K号: K260049 · 2026-04-07

决定日期2026-04-07

产品代码SEI

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决定实质等同

器械摘要

Elecsys Anti-HBc IgM is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2026-04-07 under 510(k) number K260049. The device is classified under product code SEI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elecsys Anti-HBc IgM?

Elecsys Anti-HBc IgM is a medical device that received FDA 510(k) clearance on 2026-04-07. The listed applicant is Roche Diagnostics. The 510(k) number is K260049.

When did Elecsys Anti-HBc IgM receive FDA 510(k) clearance?

Elecsys Anti-HBc IgM received FDA 510(k) clearance on 2026-04-07, under 510(k) number K260049.

Who is the listed applicant for Elecsys Anti-HBc IgM?

FDA 510(k)记录显示罗氏诊断公司为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Elecsys Anti-HBc IgM?

The FDA product code for Elecsys Anti-HBc IgM is SEI.

列明Roche Diagnostics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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