FDA applicant

Drg Intl., Inc.

East Stroudsburg, PA4 decisions2000–20082 recalls

FDA records 4 decisions for Drg Intl., Inc. (East Stroudsburg, PA) from 2000 to 2008: 4 510(k) clearances. Most are in product codes CDZ (Radioimmunoassay, Testosterones And…) and JLX (Radioimmunoassay, 17-Hydroxyprogesterone). 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, clinical chemistry panel, where it files most

How often FDA has decided Drg Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2024

2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

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Drg Intl., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?