ACA PLUS FREE THYROXINE(FT4) METHOD— 510(k) K962602

Name: FDA 510(k) clearance K962602
Creator: U.S. Food and Drug Administration
Published: 1996-08-15

Substantially Equivalent

Dade Intl., Inc.

FDA 510(k) clearance K962602 for ACA PLUS FREE THYROXINE(FT4) METHOD, Substantially Equivalent on 1996-08-15. Applicant: Dade Intl., Inc.. Device class: 2.

Clearance details

Applicant: Dade Intl., Inc.
Product code: Code CEC
Device class: Class 2
Regulation: 21 CFR 862.1695
Advisory panel: Clinical Chemistry
Date received: 1996-07-02
Decision date: 1996-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, 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 Dade Intl., Inc.

view all

K974343 — DADE INNOVIN1998-07-22
K970505 — DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/1997-11-17
K973974 — DADE TRU-LIQUID CARDIAC CONTROL1997-11-06
K973668 — CARDIAC TROPONIN-I (TROP) CALIBRATOR1997-10-20
K972524 — DRIED GRAM-POSITIVE MIC/COMBO PANELS1997-09-08

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.