K243462
- 510(k) number
- K243462
- Device name
- Diazyme Colorimetric Lithium Assay
- Applicant
- Diazyme Laboratories, Inc. CA · US
- Product code
- NDW — Assay, Porphyrin, Spectrophotometry, Lithium
- Decision date
- 2025-08-01
- Date received
- 2024-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K243462
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.