FDA applicant

Mardx Diagnostics, Inc.

Scotch Plains, NJ8 decisions1989–19970 recalls

FDA records 8 decisions for Mardx Diagnostics, Inc. (Scotch Plains, NJ) from 1989 to 1997: 8 510(k) clearances. Most are in product codes LSR (Reagent, Borrelia Serological Reagent) and LRM (Anti-Dna Antibody (Enzyme-Labeled), Antigen…). 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 Mardx Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mardx Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Mardx”

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

Mardx, Inc. 1

Mardx Diagnostics, 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?

Other applicant names beginning “Mardx”