510(k) Report

FDA applicant

Chromogenix AB

Franklin, OH4 decisions1992–19960 recalls

FDA records 4 decisions for Chromogenix AB (Franklin, OH) from 1992 to 1996: 4 510(k) clearances. Most are in product codes KFF (Assay, Heparin) and GGW (Test, Time, Partial Thromboplastin). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Chromogenix AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Chromogenix AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Chromogenix AB 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?

  • KFFAssay, Heparin1decision
  • GGWTest, Time, Partial Thromboplastin1decision
  • GGPTest, Qualitative And Quantitative Factor Deficiency1decision
  • JBQAntithrombin Iii Quantitation1decision

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 8 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.

  • K963111Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V SChromogenix AB · 19965cite it
  • K922201Coamate Protein C Chromogenic AssayChromogenix AB · 19923cite it

What has FDA decided for it lately?

  • K963111Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V SChromogenix AB · 1996
  • K952515Coacute Antithrombin R Chromogenic AssayChromogenix AB · 1996
  • K952514Coacute HeparinChromogenix AB · 1995
  • K922201Coamate Protein C Chromogenic AssayChromogenix AB · 1992

All 4 as Chromogenix AB →