FDA 510(k)

Atellica CH Diazo Total Bilirubin (D_TBil)

K-Number: K251998 · 2026-02-27

ApplicantSiemens Healthcare Diagnostics, Inc.

Decision Date2026-02-27

Product CodeCIG

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Atellica CH Diazo Total Bilirubin (D_TBil) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-02-27 under 510(k) number K251998. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atellica CH Diazo Total Bilirubin (D_TBil)?

Atellica CH Diazo Total Bilirubin (D_TBil) is a medical device that received FDA 510(k) clearance on 2026-02-27. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K251998.

When did Atellica CH Diazo Total Bilirubin (D_TBil) receive FDA 510(k) clearance?

Atellica CH Diazo Total Bilirubin (D_TBil) received FDA 510(k) clearance on 2026-02-27, under 510(k) number K251998.

Who is the listed applicant for Atellica CH Diazo Total Bilirubin (D_TBil)?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atellica CH Diazo Total Bilirubin (D_TBil)?

The FDA product code for Atellica CH Diazo Total Bilirubin (D_TBil) is CIG.

Other records listing Siemens Healthcare Diagnostics, Inc. as applicant

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Related Devices (Code: CIG)

K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc.K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223324Total Bilirubin2Abbott Ireland Diagnostics Division K190807VITROS XT Chemistry Products TBIL-ALKP SlidesOrtho-Clinical Diagnostics, Inc.K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1Elitechgroup

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.