FDA applicant
American Scientific Products
FDA records 28 decisions for American Scientific Products (Mchenry, IL) from 1981 to 1986: 28 510(k) clearances. Most are in product codes GIE (Fibrometer) and CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen). 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 American Scientific Products’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for American Scientific Products since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like American Scientific Products’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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