Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

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)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
235 (all years; only the last 3 years are listed here)

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).