FDA applicant
Meridian Bioscience, Inc.
FDA records 39 decisions for Meridian Bioscience, Inc. (Cincinnati, OH) from 2003 to 2025: 37 510(k) clearances, 1 De Novo grant and 1 original PMA approval. Most are in product codes LYR (Helicobacter Pylori) and PSZ (Devices Detecting Influenza A, B, And C Virus…). Its devices cite 42 predicates, 11 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Meridian Bioscience, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Meridian Bioscience, Inc.’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) ReportOther applicant names beginning “Meridian”
FDA records each applicant name separately; these may or may not be the same firm.