K253528
- 510(k) number
- K253528
- Device name
- Atellica IM CA 19-9 II
- Applicant
- Siemens Healthcare Diagnostics, Inc. NY · US
- Product code
- NIG — System, Test, Carbohydrate Antigen (Ca19-9), For Mon
- Decision date
- 2026-08-10
- Date received
- 2025-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253528.pdf
Official FDA record: K253528
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.