FDA 510(k)

Optilite IgM Kit

K号: K191635 · 2019-07-15

决定日期2019-07-15

产品代码CFN

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决定实质等同

器械摘要

Optilite IgM Kit is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2019-07-15 under 510(k) number K191635. The device is classified under product code CFN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Optilite IgM Kit?

Optilite IgM Kit is a medical device that received FDA 510(k) clearance on 2019-07-15. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K191635.

When did Optilite IgM Kit receive FDA 510(k) clearance?

Optilite IgM Kit received FDA 510(k) clearance on 2019-07-15, under 510(k) number K191635.

Who is the listed applicant for Optilite IgM Kit?

The FDA 510(k) record lists The Binding Site Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optilite IgM Kit?

The FDA product code for Optilite IgM Kit is CFN.

列明The Binding Site Group , Ltd.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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官方来源

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