510(k) Report

FDA applicant

Allelix Diagnostics, Inc.

Canada L4v 1p1, CA2 decisions1988–19890 recalls

FDA records 2 decisions for Allelix Diagnostics, Inc. (Canada L4v 1p1, CA) from 1988 to 1989: 2 510(k) clearances. Most are in product codes GTZ (Antisera, All Groups, Streptococcus Spp.) and GMP (Antisera, Control For Nontreponemal Tests). 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 Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • GTZAntisera, All Groups, Streptococcus Spp.1decision
  • GMPAntisera, Control For Nontreponemal Tests1decision

What has FDA decided for it lately?

  • K885298Visuwell Reagin Test 960 Test KitAllelix Diagnostics, Inc. · 1989
  • K880665Modified Group a Streptococcus Detection KitAllelix Diagnostics, Inc. · 1988

All 2 as Allelix Diagnostics, Inc. →

Other applicant names beginning “Allelix”

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

Allelix, Inc. 2