510(k) Report

FDA applicant

Quantase, Ltd.

Perth, Scotland, GB4 decisions1999–20001 recall

FDA records 4 decisions for Quantase, Ltd. (Perth, Scotland, GB) from 1999 to 2000: 4 510(k) clearances. Most are in product codes JIA (Enzymatic Methods, Galactose) and JNB (Ninhydrin And L-Leucyl-L-Alanine…). 1 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Quantase, Ltd. since 2007.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Quantase, Ltd. 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?

  • JIAEnzymatic Methods, Galactose2decisions
  • JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine2decisions

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.

  • K990654Quantase Total Galactose Screening Assay 500 Test KitQuantase, Ltd. · 19991cites it

What has FDA decided for it lately?

  • K000754Quantase Phenylalanine Screening Assay 500 Test KitQuantase, Ltd. · 20001 recall
  • K990644Quantase Total Galactose Screening AssayQuantase, Ltd. · 19991 recall
  • K990654Quantase Total Galactose Screening Assay 500 Test KitQuantase, Ltd. · 19991 recall
  • K984463Quantase Phe/Gal Screening AssayQuantase, Ltd. · 1999

All 4 as Quantase, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K000754Quantase Neonatal Elution Buffer, a component of Quantase Neonatal Accessory Kits (#1, 2…Jan 26, 2010