510(k) Report

FDA applicant

Abx, Inc.

Horsham, PA4 decisions1987–19960 recalls

FDA records 4 decisions for Abx, Inc. (Horsham, PA) from 1987 to 1996: 4 510(k) clearances. All are in product code GKZ (Counter, Differential Cell). 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 Abx, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Abx, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Abx, 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?

  • GKZCounter, Differential Cell4decisions

Who builds on its devices?

Later devices cite its devices 5 times; 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.

  • K962633Vega Hematology AnalyzerAbx, Inc. · 19964cite it
  • K895127ARGOSAbx, Inc. · 19891cites it

What has FDA decided for it lately?

  • K962633Vega Hematology AnalyzerAbx, Inc. · 1996
  • K895127ARGOSAbx, Inc. · 1989
  • K880616Minos Automatic Cell CounterAbx, Inc. · 1988
  • K864579Minos Automatic Cell CounterAbx, Inc. · 1987

All 4 as Abx, Inc. →