FDA applicant

Akonni Biosystems, Inc.

Frederick, MD1 decision2019–20190 recalls

FDA records 1 decision for Akonni Biosystems, Inc. (Frederick, MD) in 2019: 1 510(k) clearance. All are in product code ODW (Cytochrome P450 2c9 (Cyp450 2c9) Drug…). Its devices cite 1 predicate, 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 toxicology panel, where it files most

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

FDA decisions per year

1in 2019

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Akonni Biosystems, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Akonni Biosystems, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?