K250588
- 510(k) number
- K250588
- Device name
- Access Rubella IgG
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
- Decision date
- 2025-11-17
- Date received
- 2025-02-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K250588.pdf
Official FDA record: K250588
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.