LEECO T3-RIA DIAGNOSTIC KIT— 510(k) K830808

Substantially Equivalent

Leeco Diagnostics, Inc.

FDA 510(k) clearance K830808 for LEECO T3-RIA DIAGNOSTIC KIT, Substantially Equivalent on 1983-04-08. Applicant: Leeco Diagnostics, Inc..

Clearance details

Applicant: Leeco Diagnostics, Inc.
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1983-03-14
Decision date: 1983-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

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.