510(k) Report

FDA applicant

Sequoia Turner Corp.

Santa Clara, CA1 decision1996–19961 recall

FDA records 1 decision for Sequoia Turner Corp. (Santa Clara, CA) in 1996: 1 510(k) clearance. All are in product code GKZ (Counter, Differential Cell). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, hematology panel, where it files most

How often FDA has decided Sequoia Turner Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sequoia Turner Corp. since 2007.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Sequoia Turner Corp. 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?

  • GKZCounter, Differential Cell1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K960427Abbott Cell-Dyn 3500R SystemSequoia Turner Corp. · 19961cites it

What has FDA decided for it lately?

  • K960427Abbott Cell-Dyn 3500R SystemSequoia Turner Corp. · 19961 recall

The one decision as Sequoia Turner Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K913305Abbott CELL-DYN 3500 Hematology AnalyzerMay 11, 2007