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FDA 510(k)

Total Bilirubin2

K-Number: K223324 · 2022-12-29

ApplicantAbbott Ireland Diagnostics Division
Decision Date2022-12-29
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Total Bilirubin2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Ireland Diagnostics Division. It received FDA 510(k) clearance on 2022-12-29 under 510(k) number K223324. 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 Total Bilirubin2?

Total Bilirubin2 is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Abbott Ireland Diagnostics Division. The 510(k) number is K223324.

When did Total Bilirubin2 receive FDA 510(k) clearance?

Total Bilirubin2 received FDA 510(k) clearance on 2022-12-29, under 510(k) number K223324.

Who is the listed applicant for Total Bilirubin2?

The FDA 510(k) record lists Abbott Ireland Diagnostics Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Total Bilirubin2?

The FDA product code for Total Bilirubin2 is CIG.

Other records listing Abbott Ireland Diagnostics Division as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223317Alkaline Phosphatase2K203597Cholesterol2K203771Urea Nitrogen2K210633Amylase2K210452Creatinine2K203530Albumin BCP2

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Related Devices (Code: CIG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc.K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.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.

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