510(k) Report

FDA applicant

Bioquest

Mchenry, IL3 decisions1976–19790 recalls

FDA records 3 decisions for Bioquest (Mchenry, IL) from 1976 to 1979: 2 510(k) clearances and 1 original PMA approval. Most are in product codes JSX (Kit, Identification, Neisseria Gonorrhoeae) and JSG (Culture Media, Non-Selective And…). 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Bioquest since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bioquest 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?

  • JSXKit, Identification, Neisseria Gonorrhoeae1decision
  • JSGCulture Media, Non-Selective And Non-Differential1decision
  • JTODiscs, Strips And Reagents, Microorganism Differentiation1decision

What has FDA decided for it lately?

  • P770002Gonococcal Pili Antibody TestBioquest · 1979
  • K761209Taxo Discs for Diff. of AnaerobesBioquest · 1976
  • K760764Yeast Assimilation AgarBioquest · 1976

All 3 as Bioquest →