K-number	K243462
Device name	Diazyme Colorimetric Lithium Assay
Applicant	Diazyme Laboratories, Inc.
Product code	NDW
Device class	Class II
Decision date	Aug 1, 2025
Decision	Substantially Equivalent
Regulation	862.3560

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Diazyme Colorimetric Lithium Assay is an in vitro diagnostic kit that quantitatively measures lithium levels in human serum or EDTA plasma. It is used to monitor drug dosage in patients with bipolar disorder to ensure therapeutic efficacy and prevent lithium toxicity.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Diazyme Colorimetric Lithium Assay

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