FDA 510(k)

Diazyme 免疫球蛋白A测定；Diazyme 免疫球蛋白G测定；Diazyme 免疫球蛋白M测定

K号: K252336 · 2026-04-24

决定日期2026-04-24

产品代码

决定实质等同

器械摘要

Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M 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 2026-04-24 under 510(k) number K252336. FDA Decision: Substantially Equivalent.

常见问题

What is the Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay?

Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Diazyme Laboratories, Inc.. The 510(k) number is K252336.

When did Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay receive FDA 510(k) clearance?

Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay received FDA 510(k) clearance on 2026-04-24, under 510(k) number K252336.

Who is the listed applicant for Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay?

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

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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查看所有 11 个设备 →

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

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列明Diazyme Laboratories, Inc.为申报人的其他记录

官方来源