510(k) Report

FDA applicant

Control Diagnostics

Mchenry, IL2 decisions1983–19840 recalls

FDA records 2 decisions for Control Diagnostics (Mchenry, IL) from 1983 to 1984: 2 510(k) clearances. Most are in product codes JPK (Mixture, Hematology Quality Control) and LIZ (Assay, T Lymphocyte Surface Marker). 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 Control Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Control Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Control 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?

  • JPKMixture, Hematology Quality Control1decision
  • LIZAssay, T Lymphocyte Surface Marker1decision

What has FDA decided for it lately?

  • K833929White Blood Cells Human Tand BControl Diagnostics · 1984
  • K830864White Blood Cell ControlControl Diagnostics · 1983

All 2 as Control Diagnostics →

Other applicant names beginning “Control”

FDA records each applicant name separately; these may or may not be the same firm.

Control-X, Inc. 9Control Medical Technology 4Control Solutions, Inc. 2Control Print Limited 1Control Resource Systems, Inc. 1Control-X Medical, Inc. 1Control Medical Technology, Inc. / Dba Ventiv Scientific 1