FDA applicant

Leeco Diagnostics, Inc.

Southfield, MI49 decisions1979–19890 recalls

FDA records 49 decisions for Leeco Diagnostics, Inc. (Southfield, MI) from 1979 to 1989: 49 510(k) clearances. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and CDZ (Radioimmunoassay, Testosterones And…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Leeco Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Leeco Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Leeco Diagnostics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Leeco Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Leeco Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?