FDA applicant

Repromedix Corp.

Woburn, MA3 decisions2000–20000 recalls

FDA records 3 decisions for Repromedix Corp. (Woburn, MA) in 2000: 3 510(k) clearances. Most are in product codes CDP (Radioimmunoassay, Total Triiodothyronine) and JLW (Radioimmunoassay, Thyroid-Stimulating Hormone). 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 Repromedix Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Repromedix Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Repromedix Corp.

Which product codes does it file in?

What has FDA decided for it lately?