FDA applicant

Elan Holdings, Inc.

Brea, CA12 decisions1999–20010 recalls

FDA records 12 decisions for Elan Holdings, Inc. (Brea, CA) from 1999 to 2001: 12 510(k) clearances. Most are in product codes JGS (Electrode, Ion Specific, Sodium) and LBS (Ldl & Vldl Precipitation, Cholesterol Via…). 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 Holdings, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Elan Holdings, Inc.’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 Diagnostics 13 Elan Pharma, Inc. 4 Elan Medical Technologies, Ltd. 2

Elan Holdings, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Elan”