510(k) Report

FDA applicant

Advanced Clinical Diagnostics

Toledo, OH19 decisions1988–19940 recalls

FDA records 19 decisions for Advanced Clinical Diagnostics (Toledo, OH) from 1988 to 1994: 19 510(k) clearances. Most are in product codes KIR (Cells, Animal And Human, Cultured) and LLH (Reagents, Clostridium Difficile Toxin). 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 Advanced Clinical Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Clinical Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Clinical 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?

  • KIRCells, Animal And Human, Cultured18decisions
  • LLHReagents, Clostridium Difficile Toxin1decision

What has FDA decided for it lately?

  • K936171Transformed Primary Human Embryonal KidneyAdvanced Clinical Diagnostics · 1994
  • K936169Rhesus Monkey Kidney CellsAdvanced Clinical Diagnostics · 1994
  • K936172Rhesus Monkey Kidney Cells (LLC-MK2)Advanced Clinical Diagnostics · 1994
  • K934934Rabbit Kidney Cells - R.K.C.Advanced Clinical Diagnostics · 1994
  • K934973Hela-229/Hela CellsAdvanced Clinical Diagnostics · 1994
  • K935766Primary African Green Monkey Kidney CellsAdvanced Clinical Diagnostics · 1994
  • K935337Rhabdomyosarcoma CellsAdvanced Clinical Diagnostics · 1994
  • K935339Hela Hela Epitheloid CarcinomaAdvanced Clinical Diagnostics · 1994

All 19 as Advanced Clinical Diagnostics →