K243168
- 510(k) number
- K243168
- Device name
- Alinity i Rubella IgG
- Applicant
- Abbott Laboratories IL · US
- Product code
- LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
- Decision date
- 2025-06-20
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K243168.pdf
Official FDA record: K243168
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.