FDA applicant

Abacus Diagnostics

West Hills, CA1 decision1998–19980 recalls

FDA records 1 decision for Abacus Diagnostics (West Hills, CA) in 1998: 1 510(k) clearance. All are in product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). 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 Abacus Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Abacus Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Abacus Diagnostics

Which product codes does it file in?

What has FDA decided for it lately?