FDA applicant

Disease Detection International, Inc.

Irvine, CA20 decisions1988–19940 recalls

FDA records 20 decisions for Disease Detection International, Inc. (Irvine, CA) from 1988 to 1994: 20 510(k) clearances. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and LFX (Enzyme Linked Immunoabsorbent Assay, Rubella). 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 Disease Detection International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Disease Detection International, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Disease Detection International, Inc.

Which product codes does it file in?

What has FDA decided for it lately?