K253358
- 510(k) number
- K253358
- Device name
- Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
- Applicant
- Diazyme Laboratories, Inc. CA · US
- Product code
- DFH — Kappa, Antigen, Antiserum, Control
- Decision date
- 2025-12-19
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253358.pdf
Official FDA record: K253358
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.