PHASE II FREE T4 KIT— 510(k) K840901

Name: FDA 510(k) clearance K840901
Creator: U.S. Food and Drug Administration
Published: 1984-04-25

Substantially Equivalent

Medical & Scientific Designs, Inc.

FDA 510(k) clearance K840901 for PHASE II FREE T4 KIT, Substantially Equivalent on 1984-04-25. Applicant: Medical & Scientific Designs, Inc.. Device class: 2.

Clearance details

Applicant: Medical & Scientific Designs, Inc.
Product code: Code CEC
Device class: Class 2
Regulation: 21 CFR 862.1695
Advisory panel: Clinical Chemistry
Date received: 1984-02-28
Decision date: 1984-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, 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 Medical & Scientific Designs, Inc.

view all

K862960 — PHASE II FERRITIN RADIOIMMUNOASSAY KIT1986-08-27
K853224 — PHASE II B-12/FOLATE KIT1985-10-03
K840328 — PHASE II HCG KIT1984-04-19
K834219 — PHASE II CORTISOL KIT1984-02-04
K833789 — PHASE II THEOPHYLLINE RADIOIMMUNOASSAY1984-01-24

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.