FDA 510(k)

维特罗斯 AFP

K号: K213626 · 2022-06-15

决定日期2022-06-15

产品代码LOJ

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决定实质等同

器械摘要

VITROS AFP is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2022-06-15 under 510(k) number K213626. The device is classified under product code LOJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VITROS AFP?

VITROS AFP is a medical device that received FDA 510(k) clearance on 2022-06-15. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K213626.

When did VITROS AFP receive FDA 510(k) clearance?

VITROS AFP received FDA 510(k) clearance on 2022-06-15, under 510(k) number K213626.

Who is the listed applicant for VITROS AFP?

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

What is the FDA product code for VITROS AFP?

The FDA product code for VITROS AFP is LOJ.

列明Ortho Clinical 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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