510(k) Report

FDA applicant

Technidyne Corp.

Edison, NJ2 decisions1993–19930 recalls

FDA records 2 decisions for Technidyne Corp. (Edison, NJ) in 1993: 2 510(k) clearances. Most are in product codes GGP (Test, Qualitative And Quantitative Factor…) and JPA (System, Multipurpose For In Vitro Coagulation…). 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 Technidyne Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Technidyne Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Technidyne 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?

  • GGPTest, Qualitative And Quantitative Factor Deficiency1decision
  • JPASystem, Multipurpose For In Vitro Coagulation Studies1decision

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.

  • K930068Hemochron Model 8000/Factor VI Premier CoagulationTechnidyne Corp. · 19931cites it

What has FDA decided for it lately?

  • K930235Hemochron/Factor VI Whole Blood Factor Viii AssayTechnidyne Corp. · 1993
  • K930068Hemochron Model 8000/Factor VI Premier CoagulationTechnidyne Corp. · 1993

All 2 as Technidyne Corp. →