K251998
- 510(k) number
- K251998
- Device name
- Atellica CH Diazo Total Bilirubin (D_TBil)
- Applicant
- Siemens Healthcare Diagnostics, Inc. DE · US
- Product code
- CIG — Diazo Colorimetry, Bilirubin
- Decision date
- 2026-02-27
- Date received
- 2025-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251998.pdf
Official FDA record: K251998
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.