Atellica CH Diazo Total Bilirubin (D_TBil)— 510(k) K251998
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K251998 for Atellica CH Diazo Total Bilirubin (D_TBil), Substantially Equivalent on 2026-02-27. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Summary
Siemens Healthcare Diagnostics' Atellica CH Diazo Total Bilirubin (D_TBil) is filed under product code CIG (Diazo Colorimetry, Bilirubin). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 862.1110. Clinical Chemistry is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Siemens Healthcare Diagnostics filed from Newark, Delaware. The decision came 245 calendar days after FDA received it (June 27, 2025 to February 27, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Product code CIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code CIG
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