FDA applicant

Fairlake Laboratories

Mchenry, IL2 decisions1983–19830 recalls

FDA records 2 decisions for Fairlake Laboratories (Mchenry, IL) in 1983: 2 510(k) clearances. Most are in product codes CDP (Radioimmunoassay, Total Triiodothyronine) and CDX (Radioimmunoassay, Total Thyroxine). 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 Fairlake Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fairlake Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Fairlake Laboratories’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Fairlake”

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

Fairlake Marketing Group, Inc. 1

Fairlake Laboratories

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Fairlake”