510(k) K251998

Device
Atellica CH Diazo Total Bilirubin (D_TBil)
Applicant
Siemens Healthcare Diagnostics, Inc.
510(k) number
K251998
Product code
CIG
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-27
Date received
2025-06-27
Regulation
862.1110
Classification name
Diazo Colorimetry, Bilirubin
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Anthony Calabro
Address
500 Gbc Dr. Newark DE US 19714 19714

FDA Registration Numbers

Source Documents

510(k) summary PDF

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