K233946
- 510(k) number
- K233946
- Device name
- IMMULITE® 2000 BR-MA
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd. GB
- Product code
- MOI — System, Test, Immunological, Antigen, Tumor
- Decision date
- 2024-03-13
- Date received
- 2023-12-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233946.pdf
Official FDA record: K233946
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.