510(k) Report

FDA applicant

Graoipore, Ltd.

Pyrmont 2009 Australia, AU1 decision1993–19930 recalls

FDA records 1 decision for Graoipore, Ltd. (Pyrmont 2009 Australia, AU) in 1993: 1 510(k) clearance. All are in product code GIR (Reagent, Russel Viper Venom). 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, hematology panel, where it files most

How often FDA has decided Graoipore, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Graoipore, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Graoipore, Ltd.’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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Which product codes does it file in?

  • GIRReagent, Russel Viper Venom1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K922326Lupo-Test RegeantGraoipore, Ltd. · 19931cites it

What has FDA decided for it lately?

  • K922326Lupo-Test RegeantGraoipore, Ltd. · 1993

The one decision as Graoipore, Ltd. →