FDA applicant
Bioarray Solutions, Ltd.
FDA records 1 decision for Bioarray Solutions, Ltd. (Warren, NJ) in 2005: 1 510(k) clearance. All are in product code LLL (Extractable Antinuclear Antibody, Antigen And…). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Bioarray Solutions, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bioarray Solutions, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bioarray Solutions, Ltd.’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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