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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 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.

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. 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.

Other records listing Diazyme Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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