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FDA 510(k)

Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay

K-Number: K252336 · 2026-04-24

ApplicantDiazyme Laboratories, Inc.
Decision Date2026-04-24
Product Code
DecisionSubstantially Equivalent

Device Summary

Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay is a medical device manufactured by Diazyme Laboratories, Inc.. It received FDA 510(k) clearance on 2026-04-24 under approval number K252336. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Diazyme Laboratories, Inc.. The 510(k) number is K252336.

When was Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay approved by the FDA?

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

What company makes 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 manufactured by Diazyme Laboratories, Inc..

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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