510(k) Report

FDA applicant

Connecticut Diagnostics, Ltd.

Mchenry, IL14 decisions1979–19910 recalls

FDA records 14 decisions for Connecticut Diagnostics, Ltd. (Mchenry, IL) from 1979 to 1991: 14 510(k) clearances. Most are in product codes CIG (Diazo Colorimetry, Bilirubin) and GGK (Products, Red-Cell Lysing Products). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Connecticut Diagnostics, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Connecticut Diagnostics, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Connecticut”

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