FDA applicant
Bioware Products
FDA records 4 decisions for Bioware Products (Mchenry, IL) from 1980 to 1981: 4 510(k) clearances. Most are in product codes CIN (Electrophoretic Separation, Alkaline…) and JWL (Antigen, Treponema Pallidum For Fta-Abs Test). 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 Bioware Products’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bioware Products since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bioware 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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