FDA applicant

Atherotech, Inc.

Huntington Beach, CA1 decision2007–20070 recalls

FDA records 1 decision for Atherotech, Inc. (Huntington Beach, CA) in 2007: 1 510(k) clearance. All are in product code CHH (Enzymatic Esterase--Oxidase, Cholesterol). 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 Atherotech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Atherotech, Inc.

Which product codes does it file in?

What has FDA decided for it lately?