510(k) Report

FDA applicant

Corning Nichols Diagnostics

San Juan Capistrano, CA1 decision1995–19950 recalls

FDA records 1 decision for Corning Nichols Diagnostics (San Juan Capistrano, CA) in 1995: 1 510(k) clearance. All are in product code CFL (Radioimmunoassay, Human Growth Hormone). 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 Corning Nichols Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Corning Nichols Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Corning”

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