FDA applicant

American Biological Technologies, Inc.

Seguin, TX4 decisions2008–20090 recalls

FDA records 4 decisions for American Biological Technologies, Inc. (Seguin, TX) from 2008 to 2009: 4 510(k) clearances. All are in product code JJX (Single (Specified) Analyte Controls (Assayed…). Its devices cite 6 predicates, 0 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 chemistry panel, where it files most

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

FDA decisions per year

3in 2009

2008high 3 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — American Biological Technologies, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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American Biological Technologies, Inc.

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?