FDA applicant

Nichols Institute

San Juan Capistrano, CA15 decisions1990–19960 recalls

FDA records 15 decisions for Nichols Institute (San Juan Capistrano, CA) from 1990 to 1996: 15 510(k) clearances. Most are in product codes CFL (Radioimmunoassay, Human Growth Hormone) and GGT (Assay, Erythropoietin). 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 Nichols Institute’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nichols Institute since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Nichols”

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

Nichols Institute Diagnostics 68

Nichols Institute

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Nichols”