Diazyme Colorimetric Lithium Assay— 510(k) K243462

Name: FDA 510(k) clearance K243462
Creator: U.S. Food and Drug Administration
Published: 2025-08-01

Substantially Equivalent

Diazyme Laboratories, Inc.

FDA 510(k) clearance K243462 for Diazyme Colorimetric Lithium Assay, Substantially Equivalent on 2025-08-01. Applicant: Diazyme Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Diazyme Laboratories, Inc.
Product code: Code NDW
Device class: Class 2
Regulation: 21 CFR 862.3560
Advisory panel: Clinical Toxicology
Date received: 2024-11-08
Decision date: 2025-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

Download summary PDF View on FDA.gov ↗

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