AXSYM FREE THYROXINE ( FREE T4 )— 510(k) K934544

Name: FDA 510(k) clearance K934544
Creator: U.S. Food and Drug Administration
Published: 1994-06-21

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K934544 for AXSYM FREE THYROXINE ( FREE T4 ), Substantially Equivalent on 1994-06-21. 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: 1993-09-22
Decision date: 1994-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEC

view all

K240273 — Access Free T42024-03-06
K220456 — Elecsys FT4 IV2023-04-07
K182423 — MAGLUMI 2000 FT42018-10-04
K181233 — Elecsys FT4 III2018-09-18
K173122 — Abbott Architect Free T42017-10-27

More clearances from Abbott Laboratories

view all

K252424 — Anti-HCV Next2026-04-28
K243500 — ARCHITECT iGentamicin2025-07-09
K243168 — Alinity i Rubella IgG2025-06-20
K243283 — Alinity h-series System2025-02-20
K233932 — Alinity i Toxo IgM2024-08-30

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.