Source document or public record
FDA 510(k) K251998 — Atellica CH Diazo Total Bilirubin (D_TBil)
FDA 510(k) index record K251998. Device: Atellica CH Diazo Total Bilirubin (D_TBil). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2026-02-27.
Source
"device_name": "Atellica CH Diazo Total Bilirubin (D_TBil)"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K251998.
Device name: Atellica CH Diazo Total Bilirubin (D_TBil). Applicant as listed: Siemens Healthcare Diagnostics, Inc..
Decision date: 2026-02-27. Decision wording: Substantially Equivalent.
Product code: CIG. Regulation: 21 CFR 862.1110. Medical specialty: Clinical Chemistry.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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