510(k) Report

FDA applicant

Pro-Lab, Inc.

Ontario Canada M5m 1c9, CA27 decisions1984–19950 recalls

FDA records 27 decisions for Pro-Lab, Inc. (Ontario Canada M5m 1c9, CA) from 1984 to 1995: 27 510(k) clearances. Most are in product codes JSK (Supplement, Culture Media) and JTO (Discs, Strips And Reagents, Microorganism…). 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, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pro-Lab, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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