510(k) Report

FDA applicant

Scimedx Tekfile Services

Denvill, NJ1 decision1997–19970 recalls

FDA records 1 decision for Scimedx Tekfile Services (Denvill, NJ) in 1997: 1 510(k) clearance. All are in product code GMT (Antigens, Ha, Treponema Pallidum). 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Scimedx Tekfile Services since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • GMTAntigens, Ha, Treponema Pallidum1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K971502Serodia TP-PAScimedx Tekfile Services · 19971cites it

What has FDA decided for it lately?

  • K971502Serodia TP-PAScimedx Tekfile Services · 1997

The one decision as Scimedx Tekfile Services →

Other applicant names beginning “Scimedx”

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

Scimedx Corp. 14