510(k) Report

FDA applicant

Gilford

Oberlin, OH10 decisions1981–19850 recalls

FDA records 10 decisions for Gilford (Oberlin, OH) from 1981 to 1985: 10 510(k) clearances. Most are in product codes JJE (Analyzer, Chemistry (Photometric, Discrete)…) and CZP (Iga, Antigen, Antiserum, Control). 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 Gilford’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gilford since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Gilford”

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