FDA applicant

International Enzymes, Inc.

Fallbrook, CA7 decisions1994–20010 recalls

FDA records 7 decisions for International Enzymes, Inc. (Fallbrook, CA) from 1994 to 2001: 7 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and DCK (C-Reactive Protein, Antigen, Antiserum, 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 International Enzymes, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for International Enzymes, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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International Enzymes, 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?