FDA applicant

Kallestad Diag, A Div. of Erbamont, Inc.

Chaska, MN58 decisions1987–19910 recalls

FDA records 58 decisions for Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, MN) from 1987 to 1991: 58 510(k) clearances. Most are in product codes DCF (Albumin, Antigen, Antiserum, Control) and LJC (Enzyme Linked Immunoabsorbent Assay…). 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, immunology panel, where it files most

How often FDA has decided Kallestad Diag, A Div. of Erbamont, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kallestad Diag, A Div. of Erbamont, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Kallestad”

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

Kallestad Laboratories, Inc. 92

Kallestad Diag, A Div. of Erbamont, 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?

Other applicant names beginning “Kallestad”