FDA applicant

Unchanged

San Clemente, CA1 decision1999–19990 recalls

FDA records 1 decision for Unchanged (San Clemente, CA) in 1999: 1 510(k) clearance. All are in product code MSW (System, Test, Thyroglobulin). 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Unchanged since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Unchanged

Which product codes does it file in?

What has FDA decided for it lately?