Cleared Traditional

Atellica CH Diazo Total Bilirubin (D_TBil)

K251998 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Feb 2026
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K251998 is an FDA 510(k) clearance for the Atellica CH Diazo Total Bilirubin (D_TBil), a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on February 27, 2026, 245 days after receiving the submission on June 27, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K251998 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2025
Decision Date February 27, 2026
Days to Decision 245 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIG — Diazo Colorimetry, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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