FDA applicant

Gilford Diagnostics

Mchenry, IL50 decisions1978–19830 recalls

FDA records 50 decisions for Gilford Diagnostics (Mchenry, IL) from 1978 to 1983: 50 510(k) clearances. Most are in product codes JIX (Calibrator, Multi-Analyte Mixture) and JIS (Calibrator, Primary). 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 Gilford Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gilford Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Gilford”

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

Gilford Instrument Laboratories, Inc. 16 Gilford 10

Gilford Diagnostics

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Gilford”