510(k) Report

FDA applicant

General Diagnostics

Mchenry, IL39 decisions1976–19881 recall

FDA records 39 decisions for General Diagnostics (Mchenry, IL) from 1976 to 1988: 39 510(k) clearances. Most are in product codes JTN (Susceptibility Test Discs, Antimicrobial) and DIF (Drug Mixture Control Materials). 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for General Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — General Diagnostics 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?

  • JTNSusceptibility Test Discs, Antimicrobial12decisions
  • DIFDrug Mixture Control Materials3decisions
  • GJATest, Thrombin Time3decisions
  • DISEnzyme Immunoassay, Barbiturate2decisions
  • CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes1decision
  • JPASystem, Multipurpose For In Vitro Coagulation Studies1decision

Also: JBN (1), LDJ (1), LLG (1), JCA (1), CDT (1), CHH (1).

Who builds on its devices?

Later devices cite its devices 2 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.

  • K823453Von Willebrand Factor AssayGeneral Diagnostics · 19831cites it
  • K813564Coag-a-Mate X2General Diagnostics · 19821cites it

What has FDA decided for it lately?

  • K882663Barbiturate Enzyme Immunoassay KitGeneral Diagnostics · 1988
  • K872882Cannabinoid Enzyme Immunoassay KitGeneral Diagnostics · 1987
  • K871305Cocaine Metabolite Enzyme Immunoassay KitGeneral Diagnostics · 1987
  • K864993Quali. Enzyme Immuno. of Barbiturates in UrineGeneral Diagnostics · 1987
  • K863877Benzodiazepine Enzyme Immunoassay KitGeneral Diagnostics · 1987
  • K842307General Diag. Cefonicid 30MCG AntimicGeneral Diagnostics · 1984
  • K841465General Diagnostics Platelet AntibodyGeneral Diagnostics · 1984
  • K833709Ceftizoxime 30 MCG Antimicrobial DiskGeneral Diagnostics · 1983

All 39 as General Diagnostics →

What has been recalled?

1 recall linked to its devices; the latest:

  • K802117MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969Aug 20, 2004