K253069
- 510(k) number
- K253069
- Device name
- Lipoprotein (a) Molarity Assay
- Applicant
- Diazyme Laboratories, Inc. CA · US
- Product code
- DFC — Lipoprotein, Low-Density, Antigen, Antiserum, Contro
- Decision date
- 2026-06-16
- Date received
- 2025-09-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253069.pdf
Official FDA record: K253069
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.