510(k) Report

FDA applicant

Inverness Medical Professional Diagnostics-Binax

Scarborough, ME1 decision2007–20070 recalls

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, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

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

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Inverness Medical Professional Diagnostics-Binax by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Inverness”

FDA records each applicant name separately; these may or may not be the same firm.