FDA applicant
Ark Diagnostics, Inc.
FDA records 17 decisions for Ark Diagnostics, Inc. (Fremont, CA) from 2009 to 2024: 16 510(k) clearances and 1 De Novo grant. Most are in product codes DJG (Enzyme Immunoassay, Opiates) and NWM (Immunoassay, Anti-Seizure Drug). Since 2016 its 510(k)s took a median of 110 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 7 of them its own earlier devices. 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 Ark Diagnostics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2009.
Planning a device like Ark Diagnostics, 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