FDA applicant

Mardx, Inc.

Scotch Plains, NJ1 decision1989–19890 recalls

FDA records 1 decision for Mardx, Inc. (Scotch Plains, NJ) in 1989: 1 510(k) clearance. All are in product code LSR (Reagent, Borrelia Serological Reagent). 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, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mardx, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mardx, 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 Diagnostics, Inc. 8

Mardx, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Mardx”