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FDA 510(k)

Diazyme Colorimetric Lithium Assay

K-Number: K243462 · 2025-08-01

ApplicantDiazyme Laboratories, Inc.
Decision Date2025-08-01
Product CodeNDW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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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