FDA applicant
Nuclein, LLC
FDA records 2 decisions for Nuclein, LLC (Austin, TX) from 2024 to 2026: 2 510(k) clearances. Most are in product codes QOF (Multi-Target Respiratory Specimen Nucleic Acid…) and OCC (Respiratory Virus Panel Nucleic Acid Assay…). Its devices cite 1 predicate, 0 of them its own earlier devices. 3 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nuclein, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
3in 2025
Class I Class II/III not classified
Planning a device like Nuclein, LLC’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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