K241427
- 510(k) number
- K241427
- Device name
- Access Syphilis
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- LIP — Enzyme Linked Immunoabsorption Assay, Treponema Pall
- Decision date
- 2024-09-06
- Date received
- 2024-05-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241427.pdf
Official FDA record: K241427
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.