FDA 510(k)

Diazyme 颜色比色锂测定

K号: K243462 · 2025-08-01

决定日期2025-08-01

产品代码NDW

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决定实质等同

器械摘要

Diazyme Colorimetric Lithium Assay is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories, Inc.. It received FDA 510(k) clearance on 2025-08-01 under 510(k) number K243462. The device is classified under product code NDW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Diazyme Colorimetric Lithium Assay?

Diazyme Colorimetric Lithium Assay is a medical device that received FDA 510(k) clearance on 2025-08-01. The listed applicant is Diazyme Laboratories, Inc.. The 510(k) number is K243462.

When did Diazyme Colorimetric Lithium Assay receive FDA 510(k) clearance?

Diazyme Colorimetric Lithium Assay received FDA 510(k) clearance on 2025-08-01, under 510(k) number K243462.

Who is the listed applicant for Diazyme Colorimetric Lithium Assay?

The FDA 510(k) record lists Diazyme Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diazyme Colorimetric Lithium Assay?

The FDA product code for Diazyme Colorimetric Lithium Assay is NDW.

列明Diazyme Laboratories, Inc.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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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。

器械摘要

常见问题

相关临床试验

列明Diazyme Laboratories, Inc.为申报人的其他记录

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