LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY— 510(k) K914835

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..

Clearance details

Applicant: London Diagnostics, Inc.
Product code: Code CEC
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

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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.