FDA applicant

Biokit USA, Inc.

Barcelona, ES16 decisions1984–19930 recalls

FDA records 16 decisions for Biokit USA, Inc. (Barcelona, ES) from 1984 to 1993: 16 510(k) clearances. Most are in product codes GTQ (Antistreptolysin - Titer/Streptolysin O Reagent) and DHR (System, Test, Rheumatoid Factor). 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Biokit USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biokit USA, 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 “Biokit”

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

Biokit, S.A. 23

Biokit USA, 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 “Biokit”