K241534
- 510(k) number
- K241534
- Device name
- VITROS Immunodiagnostic Products Syphilis Reagent Pack
- Applicant
- Ortho Clinical Diagnostics GB
- Product code
- LIP — Enzyme Linked Immunoabsorption Assay, Treponema Pall
- Decision date
- 2024-08-28
- Date received
- 2024-05-30
- 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: K241534.pdf
Official FDA record: K241534
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.