FDA applicant

Kabi Pharmacia Hepar, Inc.

Franklin, OH1 decision1994–19940 recalls

FDA records 1 decision for Kabi Pharmacia Hepar, Inc. (Franklin, OH) in 1994: 1 510(k) clearance. All are in product code 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 Kabi Pharmacia Hepar, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kabi Pharmacia Hepar, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kabi Pharmacia Hepar, 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 “Kabi”

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

Kabi Diagnostica 2 Kabi Pharmacia, Inc. 2

Kabi Pharmacia Hepar, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Kabi”