FDA applicant

Ostex Intl., Inc.

Seattle, WA5 decisions1995–20010 recalls

FDA records 5 decisions for Ostex Intl., Inc. (Seattle, WA) from 1995 to 2001: 5 510(k) clearances. All are in product code JMM (Column Chromatography & Color Development…). 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 Ostex Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ostex Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Ostex Intl., Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?