FDA applicant
More Diagnostics
FDA records 16 decisions for More Diagnostics (Los Osos, CA) from 1993 to 2008: 16 510(k) clearances. Most are in product codes JJX (Single (Specified) Analyte Controls (Assayed…) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). 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 More Diagnostics’s devices, and how often a recall has named them.
FDA decisions per year
1in 2008
2007high 1 (2008) · low 0 (2007)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like More Diagnostics’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