FDA applicant

Allelix, Inc.

Canada L4v 1p1, CA2 decisions1987–19870 recalls

FDA records 2 decisions for Allelix, Inc. (Canada L4v 1p1, CA) in 1987: 2 510(k) clearances. Most are in product codes GTZ (Antisera, All Groups, Streptococcus Spp.) and JHI (Visual, Pregnancy Hcg, Prescription Use). 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 Allelix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Allelix, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Allelix”

FDA records each applicant name separately; these may or may not be the same firm.

Allelix Diagnostics, Inc. 2

Allelix, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Allelix”