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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 a medical device manufactured by Diazyme Laboratories, Inc.. It received FDA 510(k) clearance on 2025-08-01 under approval 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. It is manufactured by Diazyme Laboratories, Inc.. The 510(k) number is K243462.

When was Diazyme Colorimetric Lithium Assay approved by the FDA?

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

What company makes Diazyme Colorimetric Lithium Assay?

Diazyme Colorimetric Lithium Assay is manufactured by Diazyme Laboratories, Inc..

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

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

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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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