Abbott Architect Free T4— 510(k) K173122

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K173122 for Abbott Architect Free T4, Substantially Equivalent on 2017-10-27. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 2017-09-29
Decision date: 2017-10-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Abbot Park, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CEC

product code CEC

Malfunction: 899
Total: 899

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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