510(k) Report

FDA applicant

Novx Systems, Inc.

Rockville, MD2 decisions2007–20080 recalls

FDA records 2 decisions for Novx Systems, Inc. (Rockville, MD) from 2007 to 2008: 2 510(k) clearances. Most are in product codes DKZ (Enzyme Immunoassay, Amphetamine) and DJG (Enzyme Immunoassay, Opiates). 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 toxicology panel, where it files most

How often FDA has decided Novx Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Novx Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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