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FDA 510(k)

Atellica® CH Diazo Direct Bilirubin (D_DBil)

K-Number: K223078 · 2023-06-12

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2023-06-12
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Atellica® CH Diazo Direct Bilirubin (D_DBil) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-06-12 under approval number K223078. 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 Direct Bilirubin (D_DBil)?

Atellica® CH Diazo Direct Bilirubin (D_DBil) is a medical device that received FDA 510(k) clearance on 2023-06-12. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K223078.

When was Atellica® CH Diazo Direct Bilirubin (D_DBil) approved by the FDA?

Atellica® CH Diazo Direct Bilirubin (D_DBil) received FDA 510(k) clearance on 2023-06-12, under approval number K223078.

What company makes Atellica® CH Diazo Direct Bilirubin (D_DBil)?

Atellica® CH Diazo Direct Bilirubin (D_DBil) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for Atellica® CH Diazo Direct Bilirubin (D_DBil)?

The FDA product code for Atellica® CH Diazo Direct Bilirubin (D_DBil) is CIG.

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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.

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