Atellica IM CA 19-9 II— 510(k) K253528
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K253528 for Atellica IM CA 19-9 II, Substantially Equivalent on 2026-08-10. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Summary
Siemens Healthcare Diagnostics filed Atellica IM CA 19-9 II under product code NIG, carbohydrate antigen (CA19-9) test systems for monitoring and management of pancreatic cancer. The record doesn't expand IM.
Class II, 21 CFR 866.6010. Immunology is both the classification panel and the review panel. It was a Traditional 510(k).
Siemens filed from Tarrytown, New York. The decision came 270 calendar days after FDA received it (November 13, 2025 to August 10, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Product code NIG
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code NIG
view allMore clearances from Siemens Healthcare Diagnostics, Inc.
view allAdverse events under product code NIG
product code NIG- Malfunction
- 618
- Total
- 618
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.