FDA applicant

Kmi Diagnostics, Inc.

Minneapolis, MN6 decisions1997–20020 recalls

FDA records 6 decisions for Kmi Diagnostics, Inc. (Minneapolis, MN) from 1997 to 2002: 6 510(k) clearances. Most are in product codes JKR (Radioimmunoassay, Calcitonin) and CDZ (Radioimmunoassay, Testosterones And…). 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 Kmi Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kmi Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Kmi Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?