FDA applicant

Osmetech, Inc.

Roswell, GA4 decisions2001–20064 recalls

FDA records 4 decisions for Osmetech, Inc. (Roswell, GA) from 2001 to 2006: 4 510(k) clearances. Most are in product codes CGZ (Electrode, Ion-Specific, Chloride) and LIB (Device, General Purpose, Microbiology…). Its devices cite 10 predicates, 1 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Osmetech”.

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 Osmetech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Osmetech, Inc. since 2007.

Recalls per year

1in 2013

2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Osmetech, 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

Other applicant names beginning “Osmetech”

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

Osmetech Molecular Diagnostics 3

Osmetech, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Osmetech”