Total Bilirubin2— 510(k) K223324

Substantially Equivalent

Abbott Ireland Diagnostics Division

FDA 510(k) clearance K223324 for Total Bilirubin2, Substantially Equivalent on 2022-12-29. Applicant: Abbott Ireland Diagnostics Division.

Clearance details

Applicant: Abbott Ireland Diagnostics Division
Product code: Code CIG
Advisory panel: Clinical Chemistry
Date received: 2022-10-31
Decision date: 2022-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longsford, IE

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.