FDA applicant

Environmental Diagnostics, Inc.

Burlington, NC6 decisions1987–19910 recalls

FDA records 6 decisions for Environmental Diagnostics, Inc. (Burlington, NC) from 1987 to 1991: 6 510(k) clearances. Most are in product codes DIS (Enzyme Immunoassay, Barbiturate) and DKZ (Enzyme Immunoassay, Amphetamine). 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 Environmental Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Environmental 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 “Environmental”

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

Environmental Chemical Specialties 15 Environmental Test Systems, Inc. 8 Environmental Tectonics Corp. 3 Environmental Sciences Assoc., Inc. 2

Environmental Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Environmental”