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 a medical device manufactured by Abbott Ireland Diagnostics Division. It received FDA 510(k) clearance on 2022-12-29 under approval 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. It is manufactured by Abbott Ireland Diagnostics Division. The 510(k) number is K223324.
When was Total Bilirubin2 approved by the FDA?
Total Bilirubin2 received FDA 510(k) clearance on 2022-12-29, under approval number K223324.
What company makes Total Bilirubin2?
Total Bilirubin2 is manufactured by Abbott Ireland Diagnostics Division.
What is the FDA product code for Total Bilirubin2?
The FDA product code for Total Bilirubin2 is CIG.
Other Devices by Abbott Ireland Diagnostics Division
Related Devices (Code: CIG)
K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1Elitechgroup
K190807VITROS XT Chemistry Products TBIL-ALKP SlidesOrtho-Clinical Diagnostics, Inc.
K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc.
K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.
K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.
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.