FDA applicant

Scimedx Corp.

Denvill, NJ14 decisions1996–20010 recalls

FDA records 14 decisions for Scimedx Corp. (Denvill, NJ) from 1996 to 2001: 14 510(k) clearances. Most are in product codes MOB (Test System, Antineutrophil Cytoplasmic…) and MVM (Autoantibodies, Endomysial (Tissue…). 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, immunology panel, where it files most

How often FDA has decided Scimedx Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Scimedx Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Scimedx”

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

Scimedx Tekfile Services 1

Scimedx Corp.

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?

Other applicant names beginning “Scimedx”