LEECO CONCEP-7-BHCG LEIAD II— 510(k) K850201

Substantially Equivalent

Leeco Diagnostics, Inc.

FDA 510(k) clearance K850201 for LEECO CONCEP-7-BHCG LEIAD II, Substantially Equivalent on 1985-03-04. Applicant: Leeco Diagnostics, Inc..

Clearance details

Applicant: Leeco Diagnostics, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1985-01-18
Decision date: 1985-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southfield, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

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.