FDA applicant

Epitope Diagnostics, Inc.

San Diego, CA1 decision2005–20050 recalls

FDA records 1 decision for Epitope Diagnostics, Inc. (San Diego, CA) in 2005: 1 510(k) clearance. All are in product code KHE (Reagent, Occult Blood). 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 Epitope Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Epitope Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Epitope Diagnostics, 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 “Epitope”

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

Epitope, Inc. 2

Epitope Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Epitope”