FDA applicant

Kallestad Laboratories, Inc.

Mchenry, IL92 decisions1976–19864 recalls

FDA records 92 decisions for Kallestad Laboratories, Inc. (Mchenry, IL) from 1976 to 1986: 92 510(k) clearances. Most are in product codes DGC (Ige, Antigen, Antiserum, Control) and DHB (System, Test, Radioallergosorbent (Rast)…). 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Kallestad Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kallestad Laboratories, Inc. since 2007.

Recalls per year

1in 2010

2007high 3 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Kallestad”

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

Kallestad Diag, A Div. of Erbamont, Inc. 58

Kallestad Laboratories, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Kallestad”