LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY— 510(k) K914835

Name: FDA 510(k) clearance K914835
Creator: U.S. Food and Drug Administration
Published: 1991-12-17

Substantially Equivalent

London Diagnostics, Inc.

FDA 510(k) clearance K914835 for LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY, Substantially Equivalent on 1991-12-17. Applicant: London Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: London Diagnostics, Inc.
Product code: Code CEC
Device class: Class 2
Regulation: 21 CFR 862.1695
Advisory panel: Clinical Chemistry
Date received: 1991-10-25
Decision date: 1991-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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K911985 — LUMATAG T4 CHEMILUMINESCENCE ASSAY1991-08-02
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K905814 — LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY1991-02-04
K904458 — LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION1990-10-12
K903130 — LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY1990-09-25

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.