FDA applicant

Elan Pharma, Inc.

Brea, CA4 decisions1996–19980 recalls

FDA records 4 decisions for Elan Pharma, Inc. (Brea, CA) from 1996 to 1998: 4 510(k) clearances. Most are in product codes CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen) and CEO (Phosphomolybdate (Colorimetric), Inorganic…). 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 Pharma, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Elan Pharma, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Elan”

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

Elan Diagnostics 13 Elan Holdings, Inc. 12 Elan Medical Technologies, Ltd. 2

Elan Pharma, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Elan”