FDA applicant
Viramed Biotech AG
FDA records 7 decisions for Viramed Biotech AG (Oceanside, CA) from 2005 to 2022: 7 510(k) clearances. All are in product code LSR (Reagent, Borrelia Serological Reagent). 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 Viramed Biotech AG’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2007high 2 (2009) · low 0 (2007)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Viramed Biotech AG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report