FDA applicant
North American Biologicals, Inc.
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
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.
Planning a device like North American Biologicals, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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