FDA applicant

Pro-Lab Diagnostics

Ontario, CA5 decisions1992–19940 recalls

FDA records 5 decisions for Pro-Lab Diagnostics (Ontario, CA) from 1992 to 1994: 5 510(k) clearances. Most are in product codes LIO (Device, Specimen Collection) and GMZ (Antigens, All Types, Escherichia Coli). 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, microbiology panel, where it files most

How often FDA has decided Pro-Lab Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pro-Lab Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Pro-Lab Diagnostics

Which product codes does it file in?

What has FDA decided for it lately?