FDA applicant

Osmetech Molecular Diagnostics

Pasadena, CA3 decisions2008–20102 recalls

FDA records 3 decisions for Osmetech Molecular Diagnostics (Pasadena, CA) from 2008 to 2010: 3 510(k) clearances. Most are in product codes NUA (System, Cystic Fibrosis Transmembrane…) and ODW (Cytochrome P450 2c9 (Cyp450 2c9) Drug…). Its devices cite 7 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

How often FDA has decided Osmetech Molecular Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2008high 1 (2008) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

2in 2019

2008high 2 (2019) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Osmetech Molecular Diagnostics by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Osmetech Molecular Diagnostics’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, Inc. 4

Osmetech Molecular Diagnostics

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?

What has been recalled?

Other applicant names beginning “Osmetech”