510(k) Report

FDA applicant

Inverness Medical-Biostar, Inc.

Louisville, CO1 decision2006–20061 recall

FDA records 1 decision for Inverness Medical-Biostar, Inc. (Louisville, CO) in 2006: 1 510(k) clearance. All are in product code GMZ (Antigens, All Types, Escherichia Coli). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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-Biostar, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Inverness Medical-Biostar, Inc. since 2007.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Inverness Medical-Biostar, 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) Report

Which product codes does it file in?

  • GMZAntigens, All Types, Escherichia Coli1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K061889Biostar Oia ShigatoxInverness Medical-Biostar, Inc. · 20061cites it

What has FDA decided for it lately?

  • K061889Biostar Oia ShigatoxInverness Medical-Biostar, Inc. · 20061 recall

The one decision as Inverness Medical-Biostar, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K061889EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH…Sep 27, 2016Class II

Other applicant names beginning “Inverness”

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

Inverness Medical Innovations, Inc. 6Inverness Medical, Inc. 1Inverness Medical Professional Diagnostics 1Inverness Medical Professional Diagnostics-Binax 1