FDA applicant

Kabi Diagnostica

Danville, CA2 decisions1990–19900 recalls

FDA records 2 decisions for Kabi Diagnostica (Danville, CA) in 1990: 2 510(k) clearances. Most are in product codes JBQ (Antithrombin Iii Quantitation) and KFF (Assay, Heparin). 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 Kabi Diagnostica’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kabi Diagnostica since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Kabi”

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

Kabi Pharmacia, Inc. 2 Kabi Pharmacia Hepar, Inc. 1

Kabi Diagnostica

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Kabi”