CIG

Diazo Colorimetry, Bilirubin

Product code
CIG
Device name
Diazo Colorimetry, Bilirubin
Device class
Class 2
21 CFR
21 CFR 862.1110
Medical specialty
Clinical Chemistry
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
235

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-02-27.

NumberDecision dateApplicantDevice nameSummary
K2519982026-02-27Siemens Healthcare Diagnostics, Inc.Atellica CH Diazo Total Bilirubin (D_TBil)PDF

1 summaries are archived here for direct download.

Official FDA classification page: CIG
Classification and pathway per current FDA publications. Data from openFDA (CC0).