Abbott Architect Free T4— 510(k) K173122

Name: FDA 510(k) clearance K173122
Creator: U.S. Food and Drug Administration
Published: 2017-10-27

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K173122 for Abbott Architect Free T4, Substantially Equivalent on 2017-10-27. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CEC
Device class: Class 2
Regulation: 21 CFR 862.1695
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 ↗

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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 →

Recalls naming K173122

K-number listed on FDA's recall record

Z-0665-2019 — Alinity i Free T4 Reagent Kit, List Number 07P7030Class II·Terminated·Abbott Ireland Diagnostics Division·20181121

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173122.

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