Total Bilirubin2— 510(k) K223324
Substantially EquivalentAbbott Ireland Diagnostics Division
FDA 510(k) clearance K223324 for Total Bilirubin2, Substantially Equivalent on 2022-12-29. Applicant: Abbott Ireland Diagnostics Division. Device class: 2.
Clearance details
- Applicant
- Abbott Ireland Diagnostics Division
- Product code
- Code CIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Longsford, IE
Recent devices under product code CIG
view all- K251998 — Atellica CH Diazo Total Bilirubin (D_TBil)
- K223078 — Atellica® CH Diazo Direct Bilirubin (D_DBil)
- K222104 — Atellica® CH Diazo Total Bilirubin (D_TBil)
- K190807 — VITROS XT Chemistry Products TBIL-ALKP Slides
- K171401 — ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
More clearances from Abbott Ireland Diagnostics Division
view allData sourced from openFDA. This site is unofficial and independent of the FDA.