FDA applicant
Inverness Medical Professional Diagnostics-Binax
FDA records 1 decision for Inverness Medical Professional Diagnostics-Binax (Scarborough, ME) in 2007: 1 De Novo grant. All are in product code OAX (Plasmodium Spp. Detection Reagents). 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 Inverness Medical Professional Diagnostics-Binax’s devices, and how often a recall has named them.
FDA decisions per year
1in 2007
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Inverness Medical Professional…’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 “Inverness”
FDA records each applicant name separately; these may or may not be the same firm.