FDA applicant

American Bio Medica Corp.

Washington, DC30 decisions1997–20170 recalls

FDA records 30 decisions for American Bio Medica Corp. (Washington, DC) from 1997 to 2017: 30 510(k) clearances. Most are in product codes DKZ (Enzyme Immunoassay, Amphetamine) and DIO (Enzyme Immunoassay, Cocaine And Cocaine…). Its devices cite 17 predicates, 14 of them its own earlier devices. 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 American Bio Medica Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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American Bio Medica Corp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?