510(k) Report

FDA applicant

North American Biologicals, Inc.

Mchenry, IL6 decisions1978–19820 recalls

FDA records 6 decisions for North American Biologicals, Inc. (Mchenry, IL) from 1978 to 1982: 6 510(k) clearances. Most are in product codes KSX (Substance, Blood Grouping Of Non-Human Origin…) and KSF (Kit, Quality Control For Blood Banking Reagents). 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, hematology panel, where it files most

How often FDA has decided North American Biologicals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for North American Biologicals, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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