FDA applicant

Editek, Inc.

Burlington, NC7 decisions1994–19960 recalls

FDA records 7 decisions for Editek, Inc. (Burlington, NC) from 1994 to 1996: 7 510(k) clearances. Most are in product codes LCM (Enzyme Immunoassay, Phencyclidine) and DIS (Enzyme Immunoassay, Barbiturate). 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 toxicology panel, where it files most

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

FDA decisions per year

No FDA decision for Editek, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Editek, Inc.

Which product codes does it file in?

What has FDA decided for it lately?