FDA applicant

Adi Diagnostics, Inc.

Rexdale, Ontario, CA4 decisions1989–19910 recalls

FDA records 4 decisions for Adi Diagnostics, Inc. (Rexdale, Ontario, CA) from 1989 to 1991: 4 510(k) clearances. Most are in product codes GTZ (Antisera, All Groups, Streptococcus Spp.) and LJC (Enzyme Linked Immunoabsorbent Assay…). 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 Adi Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Adi Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?