AMERLITE MAB FT4 ASSAY— 510(k) K920247

Name: FDA 510(k) clearance K920247
Creator: U.S. Food and Drug Administration
Published: 1992-03-02

Substantially Equivalent

Eastman Kodak Company

FDA 510(k) clearance K920247 for AMERLITE MAB FT4 ASSAY, Substantially Equivalent on 1992-03-02. Applicant: Eastman Kodak Company. Device class: 2.

Clearance details

Applicant: Eastman Kodak Company
Product code: Code CEC
Device class: Class 2
Regulation: 21 CFR 862.1695
Advisory panel: Clinical Chemistry
Date received: 1992-01-21
Decision date: 1992-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, 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 Eastman Kodak Company

view all

K060550 — KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 65513862006-03-31
K060137 — KODAK ECLIPSE IMAGE PROCESSING SOFTWARE2006-03-16
K060079 — KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM2006-02-08
K060055 — KODAK PACS2006-02-07
K053347 — KODAK CARESTREAM PACS2006-01-04

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.