FDA applicant
Bioscientific
FDA records 16 decisions for Bioscientific (Mchenry, IL) from 1978 to 1981: 16 510(k) clearances. Most are in product codes HZJ (Stain, Papanicolau) and JPK (Mixture, Hematology Quality Control). 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 Bioscientific’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bioscientific since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bioscientific’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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