K242022
- 510(k) number
- K242022
- Device name
- Access Toxo IgG
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gond
- Decision date
- 2025-03-28
- Date received
- 2024-07-11
- 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: K242022.pdf
Official FDA record: K242022
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.