FDA applicant

Kabivitrum, Inc.

Walker, MI8 decisions1981–19880 recalls

FDA records 8 decisions for Kabivitrum, Inc. (Walker, MI) from 1981 to 1988: 8 510(k) clearances. Most are in product codes GGP (Test, Qualitative And Quantitative Factor…) and JBQ (Antithrombin Iii Quantitation). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Kabivitrum, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Kabivitrum, 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?