Albumin BCP2— 510(k) K203530

Substantially Equivalent

Abbott Ireland Diagnostics Division

FDA 510(k) clearance K203530 for Albumin BCP2, Substantially Equivalent on 2022-03-18. Applicant: Abbott Ireland Diagnostics Division.

Clearance details

Applicant: Abbott Ireland Diagnostics Division
Product code: Code CJW
Advisory panel: Clinical Chemistry
Date received: 2020-12-02
Decision date: 2022-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longford, IE

Download summary PDF View on FDA.gov ↗

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