FDA applicant

Elan Diagnostics

Brea, CA13 decisions1999–20030 recalls

FDA records 13 decisions for Elan Diagnostics (Brea, CA) from 1999 to 2003: 13 510(k) clearances. Most are in product codes CIG (Diazo Colorimetry, Bilirubin) and CGX (Alkaline Picrate, Colorimetry, Creatinine). 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 Elan Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Elan Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Elan Diagnostics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Elan”

FDA records each applicant name separately; these may or may not be the same firm.

Elan Holdings, Inc. 12 Elan Pharma, Inc. 4 Elan Medical Technologies, Ltd. 2

Elan Diagnostics

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Elan”