FDA 510(k)

Atellica® CH Diazo Total Bilirubin (D_TBil)

K-Number: K222104 · 2023-03-20

ApplicantSiemens Healthcare Diagnostics, Inc.

Decision Date2023-03-20

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 2023-03-20 under 510(k) number K222104. 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 2023-03-20. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K222104.

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 2023-03-20, under 510(k) number K222104.

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)

K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)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.