K233932
- 510(k) number
- K233932
- Device name
- Alinity i Toxo IgM
- Applicant
- Abbott Laboratories IL · US
- Product code
- LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gond
- Decision date
- 2024-08-30
- Date received
- 2023-12-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K233932.pdf
Official FDA record: K233932
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.