FDA applicant

Inverness Medical Innovations, Inc.

Waltham, MA6 decisions2001–20070 recalls

FDA records 6 decisions for Inverness Medical Innovations, Inc. (Waltham, MA) from 2001 to 2007: 6 510(k) clearances. Most are in product codes JJX (Single (Specified) Analyte Controls (Assayed…) and JPA (System, Multipurpose For In Vitro Coagulation…). Its devices cite 4 predicates, 0 of them its own earlier devices. 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, clinical chemistry panel, where it files most

How often FDA has decided Inverness Medical Innovations, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Inverness Medical Innovations, Inc.’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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Other applicant names beginning “Inverness”

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

Inverness Medical, Inc. 1 Inverness Medical Professional Diagnostics 1 Inverness Medical-Biostar, Inc. 1 Inverness Medical Professional Diagnostics-Binax 1

Inverness Medical Innovations, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Inverness”