FDA applicant

Nyegaard & Co. A/S

Mchenry, IL4 decisions1977–19770 recalls

FDA records 4 decisions for Nyegaard & Co. A/S (Mchenry, IL) in 1977: 4 510(k) clearances. Most are in product codes JJT (Enzyme Controls (Assayed And Unassayed)) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). 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 Nyegaard & Co. A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nyegaard & Co. A/S since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nyegaard & Co. A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Nyegaard & Co. A/S

Which product codes does it file in?

What has FDA decided for it lately?