510(k) Report

FDA applicant

Amf Biological and Diagnostics Co.

Mchenry, IL5 decisions1981–19850 recalls

FDA records 5 decisions for Amf Biological and Diagnostics Co. (Mchenry, IL) from 1981 to 1985: 5 510(k) clearances. Most are in product codes KIS (Sera, Animal And Human) and CGR (Radioimmunoassay, Cortisol). 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 Amf Biological and Diagnostics Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Amf Biological and Diagnostics Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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