FDA applicant
Novx Systems, Inc.
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
How often FDA has decided Novx Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2008
2007high 1 (2007) · low 0 (2009)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
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.
See the 510(k) Report